Love Conquers Alz

ASST. ATTY. GENERAL, RICK MOUNTCASTLE: INSPIRATION FOR HULU'S "DOPESICK"/NURSING HOME & CAREGIVER CRUSADER.

January 31, 2022 Rick Mountcastle, Susie Singer Carter and Don Priess Season 4 Episode 51
Love Conquers Alz
ASST. ATTY. GENERAL, RICK MOUNTCASTLE: INSPIRATION FOR HULU'S "DOPESICK"/NURSING HOME & CAREGIVER CRUSADER.
Show Notes Transcript

Rick Mountcastle  is not only an Assistant Attorney General for the Commonwealth of Virginia and a Retired Federal Prosecutor, he is a bonafide hero.  Rick, along with his partner, Randy Ramseyer, led the investigation and prosecution of Purdue Pharma, as well as its CEO, General Counsel, and Chief Medical Officer, in an unprecedented case, that, at the inception of the opioid crisis, held the opioid manufacturer and its top executives criminally and civilly responsible for falsely marketing OxyContin.  This case was at the center of Beth Macy's best-selling book, "Dopesick," and the the riveting, IMPORTANT, Hulu miniseries  of the same name that  premiered in October 2021. Rick is beautifully  portrayed  by Peter Sarsgaard.

I binged all eight episodes of "Dopesick" which was eyeopening and absolutely horrifying. Showrunner/Executive Producer, Danny Strong,  did an amazing job putting faces on the opioid crisis, as well as the crusaders who relentlessly pursued "Big Pharma".  (One being our guest, Rick Mountcastle.)

I was already blown away by Rick and Randy's passionate pursuit in taking down Purdue Pharma, but I literally gasped out loud when it was revealed in the last episode that they were going to go after Abbott Laboratories for falsely marketing  Depаkote, a drug that is meant to treat epilepsy, and tаrgeting nursing homes to treat agitation associated with Alzheimer's and dementia. 

Depakote is the drug responsible for rendering my otherwise healthy mother non ambulatory and incontinent in a matter of seven days.

Rick led the investigation and prosecution of Abbott Labs which resulted in criminal and civil penalties totaling $1.5 Billion (at the time the largest pharmaceutical settlement involving a single drug in U.S. history). 

I had to thank him.  I did and asked if he might share what he had learned while investigating Abbott. Turns out Abbott Labs are not the only pharma targeting the under-staffed and over-worked nursing homes.

Listen or watch this episode and TAKE NOTES.

And HUGE thanks  to my special guest co-host, Trish Humenansky-Laub , Founder of Comfort in Their Journey LLC, guiding: Alzheimer's 🐞 Dignified Care 🐞 End of Life Author•Consultant•Speaker. xoxox

And if you are interested in joining me in a coalition to get the states to regulate Skilled Nursing Homes by requiring a specific minimum level of staffing, you can DM ME.

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ANNOUNCER:

When the world has gotcha, and Alzheimer's sucks. It's an equal opportunity disease that chips away at everything we hold dear. And to date, there's no cure. So until there is we continue to fight with the most powerful tool in our arsenal. Love. This is love conquers all, a real and really positive podcast that takes a deep dive into everything Alzheimer's, The Good, the Bad, and everything in between. And now here are your hosts Susie singer Carter, and me, Don Priess.

Susie Singer Carter:

Hi, I'm Susie singer Carter. And this is Love conquers Alz. And today I have a very special co host, which I've never done before a guest co host who is another wonderful advocate in the caregiving arena and community and she's extremely active. She spoke on the Alzheimer's worldwide summit with me and I just adore her and you're gonna love her to her name is Trish Laub. Trish. I'm so excited to have you here.

Trish Laub:

I'm so excited to be a guest co host. And I have to just thank Don for letting me take his co host seat today. I'm excited to work with you. But I'm also super. super... I next to never say this. I'm really excited about the guest that you've got.

Susie Singer Carter:

I know Me too. Me too. So I don't know about you. But But there's been with the quarantine. I've been so much TV lately. That's all I mean. That's what else can we do besides eat? Right? My dog even my dogs are fat. It's sad. It's really sad. I feel bad about it. I feel not that bad, but a little bad. But you know, so but I've done a lot of binging Haven't you I've been and it's not even a guilty pleasure anymore. It's like a necessity. And I run out of really good notes and you run out of good projects, right? And so I I was I wasn't really wanting to watch this mini series dope sick. It's subject matter, which is OxyContin and the opiate crisis. And I was like, "oh, it's too close to home". Because I had a very close family member that was involved in that whole world. And but I, I decided to because I love Michael Keaton. I like Peter Sarsgaard, and I thought, Okay, let me watch it. It was so good. And then I told you about it. You watched it? How many times?

Trish Laub:

Well, okay, I watched it twice, back to back. And I'll be honest, I heard about it. And I shame on me, I thought, This is gonna be a documentary. It's gonna be probably not very riveting. And I could not have been more wrong. Like I said, I watched it back to back two times. And it was fascinating and it's absolutely horrifying at the same time. Yeah, and I know Susie from talking to you what really caught our attention was the teaser at the end of the episode.

Susie Singer Carter:

Yeah. Well, let's back it up one second. Cuz I want to say what Dope Sick was about the investigation at Purdue laboratory and the Sackler family and this dynamic duo, these internal generals from Virginia, one who is our esteemed guest, who is Rick mountcastle, who was played by Peter Sarsgaard brilliantly, and his partner Randy Ramseyer. Just riveting you guys. But then on the finale, they, you know, just when they're they're tying up the final bow, as it were, on this case, in walks another case presented by Randy to Rick about the another crisis in pharma which was a drug called Depakote, which is, has been extremely abused along with other drugs in the nursing home. And it's touched me very closely. And my mom is a victim of that of that kind of abuse. And I found it so interesting, because Danny Strong is the showrunner and he was saying, you know, the powerful thing is to put a face to crisis when you can put a human face to crisis it, it creates change, right? It's important. It's important otherwise it just noise. And so they did it brilliantly by putting us into the actual lives of these investigators and really see them be crusaders really. And then watch somebody like like Michael Keaton's character this incredibly moral and and empathetic doctor get conquered almost by this drug. So really, it really put a face on it for me. It made me frame how I looked at my family member that became addicted to it. And so it's powerful. And I think that's why I wanted -- I personally wanted to talk to Rick because he, he went on to take on another pharma which is Abbott Labs, and they manufacture Depakote, which is a drug that I didn't know anything about the struggle. My mom was getting it in the hospital and became suddenly she was in a wheelchair after being ambulatory and became incontinent. And she was she was literally like aoh, like someone had given her a lobotomy. And I didn't know until about two months after shegot out of the hospital that her GP alerted me that she was on a drug called Depakote and that it was actually quite deadly for people in the elder community. So this is it. This is absolutely terrifying. And when I got my mom off of it, she never walked again. You've had experience with that as well, Trish with your dad.

Trish Laub:

Right with my dad, not only with Depakote but another medication that's being used off label for the same kind of wrong purpose. The Depakote has been being used. But I'll let Rick get into that. What would happened with Dep akote? And that, to me my experience that applies to several other medications as well.

Susie Singer Carter:

Exactly. Well, I cannot express how esteemed this guest is. He and his partner have received the Department of Justice Achievement Award by Attorney General Eric Holder and Executive Office for US Attorneys Director, H. Marshall Jarrett, who said, and I quote that he "is continually humbled by their resiliency, dedication and unparalleled work ethic to accomplish this noble mission. Today's awardees exemplify what it truly means to be a patriot, and it is an honor to recognize them for their extraordinary service." And it's an honor for us to invite Rick mountcastle to our show. How are you, Mr. mountcastle?

Rick Mountcastle:

Well, I am just doing just great. Susie and Trish and thank you for inviting me to participate in your podcast, it's an honor. It's particularly an honor, because I view the your audience who I believe would mostly be caregivers, for patients with dementia, I view them as real heroes. I know, I've never dealt with a relative with dementia, but I have I did take care of my aging mother for a number of years. And I know how much work how much patience. How much effort goes into taking care of a loved one. And I you know, just knowing you add that on to that Alzheimer's. Those people that are in the audience, you guys are really heroes. So it's an honor for me to be here. Thank you so much for saying that. I know everyone else appreciates that we feel we feel that way about caregivers because they are the the uncelebrated heroes. And so thank you for that. Yes, there are heroes that don't get enough recognition. And so thank you for giving me this opportunity to maybe give them a little bit of recognition. I appreciate you guys so much

Susie Singer Carter:

.Ditto. well, thank you. I think we want to we're gonna jump into we have so much to ask you.

Rick Mountcastle:

Can I just say one thing before?

Susie Singer Carter:

Oh, yes.

Rick Mountcastle:

One of the things I have to do, because I'm a lawyer. So we've always got some legal, you know, fine print is I need to just put some fine print into this podcast if I can do that right now lately.

Susie Singer Carter:

Yes, legitimize us!

Rick Mountcastle:

I just want to make it clear that my statements and comments during this podcast are my personal views and opinions and are in no way related to any position with either federal or state government that I have had in the past or may have currently.

Susie Singer Carter:

We will also have that in the show notes and on the screen. So no shenanigans people.

Trish Laub:

So I know a bit about the story. But Rick, could you explain to everybody share with everybody how you and Randy became aware of the Depakote crisis and what that means?

Rick Mountcastle:

Yes, so we, at the time I lived and Randy still lives in a town called Abingdon, Virginia in far southwest Virginia not to be confused with West Virginia. It is in Virginia, in a far southwestern corner, it's a few miles from Tennessee. It's basically coal country. It's in the middle of the Appalachian Mountains. And many of the people depicted in dope sick. In those the scenes of the mining scenes, and the scenes locally, are just like the people that are depicted in that miniseries working class work very hard jobs. A lot of many of them in the coal mining industry farming other jobs in which they get injuries. And so in the late 1990s, and for for many years even before that one of the main issues in that region was the abuse of prescription drugs. that had been going on for decades down there. And in the late 1990s, we were looking at ways to get at that problem. We prosecuted a number of doctors for over prescribing opioids and other painkillers. And in the course of doing that we discovered in the late 1990s, that there's this new drug coming into play called Oxycontin. It was the drug that was in demand. It was the drug that doctors were prescribing. It was a drug that was being abused on the streets down there. And it was a drug that was fueling a lot of other crimes, property crimes, Steffes burglaries, their communities being devastated by it. And we were sitting around the office one afternoon after work talking about cases and a we're prosecuting doctors, we've got all these street drug dealers that we're going after. And we're hearing anecdotally about from pharmacists, local pharmacists, who know their community, they did small town, they know who's who's doing who's into what and who's got legitimate pain and prescriptions and the like, complaining about sales reps from Purdue pharma, who were aggressive, being aggressive, and coming into the pharmacies and demanding that they fill prescriptions, even ones that they were hesitant to fill. So in our conversations, we just were talking and said, Well, maybe we need to take a look at a level above the doctors, maybe we need to take a look at Purdue pharma and see what they're doing what's going on here. And so that kind of kicked off the case it was it was a feeling that we had an obligation to our community, which was being devastated by this drug to try to get to the root of the problem.

Susie Singer Carter:

It's interesting, because, you know, I'm in Los Angeles, the opposite of rural and you know, and, and when it started to get prevalent here it was, it was really nicknamed, like the "White Collar Heroin". You know, because it was it was it was widely abused, but nobody really talked about it because it was prescribed.

Rick Mountcastle:

Yeah, so yeah, of course, it was called down here, it was called "Hillbilly Heroin". And as was depicted in the miniseries, Purdue targeted those areas where there were a lot of people who are getting injured on the job and having go to the doctor and get painkillers like, you know, Virginia, Kentucky, sort of all those mining areas, as well as Maine where they have the lumber and the logging and all that those were like the first areas targeted to launch the drug into toxicology.

Susie Singer Carter:

Oh, that's interesting. I didn't know that. Okay, that's so interesting. So then how did you get? How did Depakote come to you? And how did you embrace that? Well, after going through this extremely grueling, long investigation, and if you haven't watched the this mini series do, because you're going to be absolutely riveted. Because you know, this, it's a daunting, I've gone to court just to protect my mom at one point. And I, I literally went three times and I had no standing and I was her her legal conservator of person. And I had no standing to make any decisions that were really important and nice to ask the judge who does then if not me, you know, and there's just no good answer. So I find the court systems extremely frustrating. So, you know, someone like to watch this and see you, you continue to prevail and be resilient. And, and and it's, it's, it's amazing. So, at the end of the episode eight, the finale, after like I said, you had button you are gone through this whole whole grueling, intense investigation with frustrations and so on and so forth. And all of a sudden, now, you're presented with another pharma fiasco. What motivated you?

Rick Mountcastle:

Well, it was it was an area that was interesting, even though it was hard, number one, number two, it was it felt like it was work that had a very huge purpose. You know, we had a national impact. And I had gotten into the business of being a lawyer and particularly being a prosecutor, because I wanted to help people on wanting to make people's lives better. So that another case like Depakote case, which was pretty clear that they were, you know, I don't want to say, well, you know, in a way abusing vulnerable people, elderly, dementia patients confined to nursing homes. I mean, I don't know how much more vulnerable you can get...

Susie Singer Carter:

... and voiceless. Yeah.

Rick Mountcastle:

Okay. So for me personally was this is the kind of this is a reason I'm doing this work. And so that was, you know, that hasn't, I will say that the hesitancy that's shown in the Hulu mini series is an exaggeration. Dramatic exaggeration. Okay.

Susie Singer Carter:

Okay. Interesting. Yeah, that's interesting. You know, you always wonder what the motivation is, and you're kind of like too good to be true. It's, I say that with such respect and love, because, I mean, I went through such a hard time, like I said, in the court system and got so disillusioned by you know, I am Pollyanna from the get go and always thought, well, right is right, the truthful will will out and it doesn't always will out. Right. Right.

Trish Laub:

So clearly, you took that case, but if you had not been through the case with Purdue pharma, do you think you would have pursued Depakote?

Rick Mountcastle:

You know, that's a difficult question to answer, I'm not sure that the Depakote case would have even come to us. And here's what I mean by that. So the Depakote case was originated by a whistleblower out of from Georgia by the name of Meredith McCoyd. And she had retained an attorney, a whistleblower attorney. And so that these cases, these pharmaceutical cases, when you have a whistleblower, they're filing a civil action under the False Claims Act. And these cases involving a national pharmaceutical company can be filed anywhere in the United States. And there are 74 US Attorney's offices, in court districts federally across the United States. So you know, that case could have been filed in any one of the 74 courts, federal courts across the United States. And I think what the reason it came to us is twofold. Number one, our success with the Purdue case had become known. So you know, was apparent that the Western District of Virginia, which very small US Attorney's Office, had some expertise and its success in that area in dealing with off label marketing of pharmaceutical. And the our partner in the Purdue case, the Virginia Attorney General's Office, Medicaid Fraud Control Unit had, you know, the, the director of that was, you know, very much in tune with, you know, he's part of there's this national organization called the National Association of Medicaid Fraud Control Units, and they have a lot of contact with whistleblower attorneys, and the head of the Virginia Medicaid Fraud Control Unit, again, and I'll speak to that group and a little bit, but I had gone and I think, somehow had a discussion with the attorney for Meredith McCoyd, and convinced them to file that case in our district. So that's how it comes to us without the Purdue case, it probably goes to one of the other districts that does more of these cases like Boston or Philadelphia. So that's how it came to us. And so two months after we after the sentencing and the Purdue case, we get this this, this new pharma case, again, working as in partnership with the Virginia Medicaid Fraud Control Unit set, yeah, I've wanted to question because when you brought up whistleblowers, I was thinking, if someone were wanted to take on that, that moniker as a as a whistleblower, in you have to go through a lawyer, is that something that is out of pocket for you? Or how does that work? The answer is no whistleblower lawyers will take on cases on a contingency basis. So, you know, if you want it to retain one, you know, they'll screen your case, they'll get your case. And if they're willing to take it, you'll have to sign some sort of an agreement that involves that there'll be able to recover their costs and they'll get a certain percentage and, you know, I'm not exactly sure it could be as much as 50% or more on the recovery. But you don't necessarily have to havea big chunk of cash going into those cases. But you do need to have a lot of information. Okay. And I would say a lot of inside information because the a whistleblower complaint, you know, they would starts off, they file a complaint in court that's under seal. There are a lot of technicalities that are involved in that kind of a legal complaint and legal proceeding. And what they're hoping is that the federal government or even a state government will do what's called it will intervene and kind of take over the case for him. But that's not necessarily a given because of how few resources there are in the government to devote to that area. But but you don't have to have, you don't have to be wealthy going in you don't have to have out of pocket money. You just have to have good information. And usually it's good inside information. That's that's really good information. Thank you. So generally, I would add that the best whistleblowers are former employees of a company, okay. And because they have they know what's going on inside the company, they know who's making decisions, they know what directives are being pushed out to sales, the sales force, you know, an outside or, you know, a consumer, a patient is probably not going to have sufficient information to have a was a, you know, a good whistleblower attorney take on their case.

Trish Laub:

So Rick, Susie and I are kind of familiar with what happened with Depakote for but but for the people who are not familiar with that. Can you explain to them what the issue was and how it was being used improperly?

Rick Mountcastle:

Yes. So in a kind of, in a nutshell, way. Depakote is a drug that's been around a long time, I forget, at least since the early 80s. It was it's approved by the Food and Drug Administration, FDA for three things. It's approved for the treatment of epileptic seizures. It's approved for the treatment of bipolar mania. And it's approved for the treatment as a prophylaxis for migraine headaches. Okay. And so what happened was in the late 1990s, Abbott Labs, who was the manufacturer of Depakote wanted to expand its market. And for a variety of reasons that we can talk about in more detail. They saw a niche in the nursing home business where Depakote where they would market Depakote for the treatment of agitation in dementia patients confined to nursing homes, which is completely off label off label meaning it's not approved by the Food and Drug Administration. And they set up a long term care division within the company to do nothing but promoted for this unapproved use, you know, they promoted it as being safe and effective to treat agitation and other behaviors that dementia patients sometimes get when you know, especially when they're an unfamiliar setting. And they have unfamiliar people taking trying to take care of them, they become combative, they become out of right. And and there are there are behavioral ways to to deal with that. Right. The main effect of Depakote for those folks was put in making sleep. So in effect, it was a chemical restraint is what you know, it's called in the business or chemical straightjacket, you know, so you have somebody that's acting out in the old days, probably way back. They used to put them in straight jackets, so they couldn't use their arms couldn't hurt themselves, somebody else. Well, that's not you don't We don't do that anymore. But give them a drug put them to sleep. And now they're not a problem. They're not being combative. They're not fighting with anybody, that kind of thing. And so they know that's just plain wrong. Right? Yeah. And you have a population that cannot cannot speak out about that.

Trish Laub:

If I'm not mistaken, is it true that it I think it was 1987 that they made that law that you cannot chemically restrain someone? That's those drugs that they had been using previously, could no longer be used unless it was protecting the safety of the person. Is that accu rate?

Rick Mountcastle:

That's accurate. Well came out and In 1987 It's called O.B.R.A. - Omnibus Budget Reconciliation Act of 1987 put into place a whole set of new standards for nursing homes. And so up to that point in time that what had been used on dementia patients who were having those kinds of behaviors and agitation and combating them is where these anti psychotic drugs like Seroquel, Zyprexa, Risperdal, which was, which were very dangerous, very, very dangerous. In fact, all those drugs I think ended up having to include a warning about the risk of death in elderly patients with dementia.

Susie Singer Carter:

Is that the same as a Black Label?

Rick Mountcastle:

Yes. Yeah. It's called a blackbox. Warning. And, yeah, we can talk about that in more detail. Definitely. I'll try not to make it too boring. But...

Susie Singer Carter:

No, it's not. Because if I didn't know that, this, my mom would, would probably not be here with us.

Rick Mountcastle:

It's a very, it's a very technical thing. So they all had black box warnings that said, Hey, you have a significantly increased risk of death, that's for these anti psychotics if they're administered to elderly patients with dementia. And so the the purpose of the 1987 law was to pull back on that to to make it more difficult for providers in nursing homes to prescribe those kinds of drugs. Unless, you know, they had to set out a specific mental health diagnosis. They had to include drug holidays, where they would take the that patient off of the drug for a Peter period of time see how they did without it, it included the requirement that they provide try other non drug measures to deal with that to behavior that agitation. Well, what Abbott saw was, well, that's, that all applies to those anti psychotics that it doesn't apply to Depakote. Okay, so we can go in and kind of swoop in and take over where they used to prescribe those anti psychotics to the for agitation in dementia patients will swoop in and say, Well, now that you guys have a problem doing that, because of the rules, you can use Depakote, and it's not subject to those rules. So so that's where all of a sudden you have this huge increase in the use of Depakote in nursing homes, to control, quote, control the agitation in dementia patients. And they push that and you know, maybe they made billions of dollars off of it.

Susie Singer Carter:

And they made it in you know, what, what, how do they do that? How do they get away with those kinds of things? Like I from what I heard, they were they were manufacturing it to make it sound so lovely, like sprinkles that they would sprinkle into the patient's food that no longer could chew, correct?

Rick Mountcastle:

Yeah, correct. So the Depakote had had black box warnings, right? Even back then, okay. It had blackbox warnings, because it had the potential to cause liver damage. It had, it was it was a warning about women who were pregnant taking it because it could cause birth defects. And there was a blackbox warning because it caused cause something called pancreas, Titus, I guess, inflammation of the pancreas. Those were the three black box warnings. But what Abbott did was that they conducted these studies. You know, and this is how, just like it was shown with Purdue in the Hulu mini series. Abbott, like all pharmaceutical companies conducted studies. And, you know, the studies were, of course, if you read them very closely, they were inconclusive at best. And we're just, you know, completely didn't help them at all, at worst. But they they cherry picked a language out of the the articles written about that studies, no studies. And so for Depakote., there was language in a study that it appears to have a beneficial effect in the treatment in patients and dementia patients with agitation. They're not they don't exhibit that agitation. But so that's the language they cherry pick, but they didn't include the additional language that that well, we're not sure whether this is due to the fact that Depakote causes somnolence so that it could be that the reason they're not agitated is because they're asleep. Okay. And that, therefore, the findings of this study are inconclusive and further studies required so they don't, they don't take that out that language, just cherry pick the parts of the study the study that is gonna be a marketing tool for that.

Susie Singer Carter:

Sure. And, yes, it's just set systemically this whole, you know, they're, they're, they're set, they had such an opening for this because, you know, our nursing skills are skilled nursing homes and our assisted living are so understaffed and, and, and, at best at the best places, you know, they there's just not enough staff, and there's no regulation for it, as far as I know, for how many, you know, the minimal amount of caregivers or nurses are needed per per resident, so you know it, I can see why it would feel attractive when you are overworked and you can't attend to all these people. I've been in situations where my mother was in one place where it was like walking into the cuckoo's nest. And and it didn't have to be, right. I mean, these are all lovely people, that people that were there were lovely, they were just not being attended to.

Trish Laub:

So, Rick, with these promotional materials that in theory, the sales staff are relying on and then the nursing homes are, in theory, relying on the accuracy of these studies and stuff, who's overseeing those marketing materials? Who's supposed to be overseeing those to see that the language is actually, you know, verifiable?

Rick Mountcastle:

Yeah. So you're referring to the government agency that is kind of overseeing that making sure that making sure the rules are being followed, right. Well, kinda. So that would, that would be the Food and Drug Administration or the FDA. And so here's the thing about the FDA is this, there's two there's two issues that that are there with the FDA. Okay. So there's an office within the FDA used to be called the Division of Drug Marketing, had this long name, the acronym was DDMAC - DD MAC. It's now called something else, but they're responsible for reviewing all the promotional materials, particularly the ones that are direct to consumer to patient, but they're responsible for reviewing all pharmaceutical company promotional materials. Now that and I was written something that back in 2010, they had a staff of 57, at FDA responsible for reviewing all promotional materials for pharmaceuticals. And during that year, there were 35,000 promotional materials that need to be reviewed by a staff of 57. So you can imagine, with that kind of ratio, they are not able, physically able to thoroughly review every piece of promotion by a pharmaceutical company.

Susie Singer Carter:

Was strategized by... or do you think that was part of their strategy to to disseminate that much material? Knowing that...

Rick Mountcastle:

No, I think this is just you have so many pharmaceutical companies out there. Okay. And that's sort of the the amount of promotional materials they put out there, but I think they know, they know. Okay, how understaffed the FDA is and how difficult it will be for an FDA employee assigned to that office to find a particular one a needle in the haystack. Right and focus in on one particular piece of promotion. That is false and fraudulent. Basicall.

Susie Singer Carter:

Eventually, Depakote did get a black label or blackbox warning for the elderly people that with dementia in particular, at least that's what my mother's GP said, "I don't know if you're aware that but this is a Black Label drug that could be deadly for someone with dementia." And and so he that's how I had first heard about I never heard of it. So did it actually have an official warning to that extent? And if so, how did it get that?

Rick Mountcastle:

Yes, Susie, I'm not aware that it had a specific blackbox warning geared towards the elderly. But if one of its main side effects is somnolence. And I as I recall, one of the other side effects, some of the other side effects. Were loss of appetite, and dehydration. Mm hmm. I think it's very easy to see how that drug could be deadly to some an elderly patient in a nursing home because because those are the things that that are very dangerous, right? Lack of malnutrition. That leads to all kinds of other problems in that setting in dehydration, right, and then somnolence. Okay, now they're just like laid out in a bed not moving, they're malnourished, and now you start to have pressure sores and all those other things.

Susie Singer Carter:

Can I add one other thing was when you're dehydrated and a lot of elderly when they're dehydrated, you know, bladder infections are a huge deal. And bladder infections are, you know, they manifest in in psychological ways. That's one of the first things they check if someone's seen combative, so what they're doing is just basically exasperating what they're trying to quell.

Rick Mountcastle:

Yes. So I think it's very easy for, you know, someone who has any kind of experience in treating geriatric patients to see, hey, if these are the this is what happens with that drug that's, that could be deadly.

Susie Singer Carter:

Yeah. And I'm lucky, I don't think everyone you know, I know that everyone doesn't have such a great doctor. I'm so thankful and grateful that he made that call to me, because without him, alerting me I would have never known I thought this was the end.

Trish Laub:

I think Susie and Rick, both are hitting on something really important. What I really learned from dope sick, and then this is is tying into the investigation. And Depakote is I had never been aware of a blackbox warning. I didn't know how to find one. I didn't know what it meant. I now understand I think the value of knowing what the FDA approved usages of a medication are. And so I'm not sure everybody that's listening don't really, you know, they may not be familiar with that terminology of a blackbox warning, and the importance of knowing the FDA usages. Rick, can you speak to that a little bit?

Rick Mountcastle:

Yes, yes. And for the caregivers that are listening, know, maybe a couple of pointers here. Number one, when the person you're taking care of has been is prescribed a medication, there's this very dense pamphlet that comes with it more than just the little label, it's on the bottom, there's, there's this you know, they pharmacy that I go to Staples, this packet of papers to the bag, which you know, it's very normal to pull it off and throw it in the trash and go and get the bottle. But if you're a caregiver, you should, you should look at that. You know, it's I know, it's, it's a little bit difficult, but look for the side effects. And look for it's the black, it's called a blackbox warning, because it's going to be in that packet of papers that label what it's called the label. That's it's going to be outlined in black. And it's the black box warning. And that black box warning is put in there. Whenever the FDA determines that based on the data, there is a very serious potential for a side effect, a very dangerous side effect, especially if it's a side effect that could result in death. That's where that's going to be and so it's very important to read that. The other thing that I think that listeners should know is that a licensed physician has the legal right to prescribe a drug off label for an unapproved use. So if you're taking care of someone, particularly if they're in a skilled nursing facility, and you're the caregiver, the and you're getting the notices when they change medications, ask questions about that. Because just because it's the order comes from a licensed physician, doesn't mean the FDA has approved it for that you need to check that you needed to read the label, understand what it's been approved for, because that's going to be in the label. And if it's if you're prescribing physician, who oftentimes is the what the physician who has the contract with the right skilled nursing facility, right, they're there, they're only part timers. They barely see a lot of those patients, they've got a busy practice and are doing this on the side. If they make a medication change, you need to be all over that. You need to check that you need to find out why you need to make sure that drug is approved for that use. And if it's not, then you've got a lot of other questions that you should be asking.

Susie Singer Carter:

Right? If you know your loved one or you're the person you're caring for. There are you will you will see changes and you need to question them. You know, I've made every mistake in the book I have like I said I thought my mom this was the progression of Alzheimer's That's what I thought. And I wouldn't have known it. So if you have any intuition or something doesn't feel right, or you know, there's a sudden change in, in the person that you're caring for it, I think it calls for further investigation of your own, just to just to be sure, what are they taking? They don't tell you. They don't. Yeah, I'm my mom's conservatory person, but I don't get a list of drugs. I have to ask for them.

Trish Laub:

Right, and Susie, you know, with my dad being and he was in skilled rehab, and they prescribed my dad at that time, had been living with Alzheimer's for probably 18 years. And I didn't know any of this stuff that we're talking about today. And a physician who never even met my father prescribed Seroquel, which is an anti psychotic. This is 2012, which is clearly after 1987. And Seroquel happens to this black box label happens to say that it can be deadly for elders living with dementia. Now I knew every cell in my body knew something was wrong. And my mom, his power of attorney went and said, you may not give this to my husband. We didn't know why. But everything just we were lucky. We were just lucky. Now I realized that, you know, if I'd had the information that we're getting today, I could have looked at medication up. I've been on the FDA website a lot lately looking. Yeah. It's not that hard to use. But yeah, I mean, getting the information that that you're providing today is actually a little bit terrifying for me, because I realize how dangerous the things that were happening to my dad really were.

Rick Mountcastle:

And you all know how many of the medication changes are done in a skilled nursing facility. Right?

Susie Singer Carter:

Tell us. Tell us,

Trish Laub:

Yes, tell us.

Susie Singer Carter:

Do tell, Rick. Do tell.

Rick Mountcastle:

Yeah, so often times, it's a nurse who sees that, oh, that patient something's going on with that patient. They're asking us and such. And they will call the doctor and say, Doctor, the, the, you know, the doctors, he's out he or she is out doing something else doing their own direct normal, you know, their, their normal job. Doctor, this is what's going on with this patient. I think you should, I think we should prescribe whatever Zyprexa, okay, or whatever. The doctor often times is just a rubber stamp for that nurse without ever seeing the patient, just based on what that nurse has told the doctor over the telephone, the doctor will approve that prescription. So especially in those in a skilled nursing setting, if there's any kind of change or an addition of medication, there's a you know, and I know this, there's so much that caregivers already have to do, and I just don't want to add another burden. But that is the one thing that needs to be questioned is because understand that the physician is making those prescriptions and making those changes in the medications oftentimes without actually laying eyes on that, that patient.

Susie Singer Carter:

It's mind blowing, it's absolutely mind blowing, it seems it's the most unconscionable thing that you could do. And yet it goes on, like you said, it's, it's, it's part of, it's part of the, that, that whole culture, that whole industry. And, and and it's it's systemic, it's scary as hell. Because like I said, we don't know what we're even if you are the legal conservatory, you're not going to you're not going to be privy to that information, you're privy to that, you know, if they need money, you know it, and it you know, that's when they get in touch with you. And so it's everything else, you have to unfortunately, like you said, what it is, is you have to be proactive, you have to advocate, you have to be the ears and the eyes and voice for the person that you're caring for and in, you know, which is why we're trying to make it easier for caregivers and to to let people know that they're doing an enormous job and, you know, we need the whole we need support from every every aspect of our society, like like you were talking about Medicaid and Medicare and, and, you know, they're, they're responsible for the regulations. Correct?

Rick Mountcastle:

So, th,e in terms of the prescribed, prescription use of prescription drugs, that's the Food and Drug Administration, so Medicare and Medicaid, they regulate sort of the they regulate the nursing homes and how the nursing homes conduct business. And one of the things that I think is a problem, is thatnone of the states and and the federal government, either the federal government nor any other states require any kind of staffing levels for for nursing home, it's all very you know, it very vague, it's must provide in the sufficient staff to provide the level of care that set forth in the regulations. So there's, there's no, a if you've got, you know, for every 15 patients, you need to have two CNAs. There's none. There's nothing like that. And that's, that's a product, again, out of the politics - of the politics of money, basically, is that the nursing home lobby, make sure that those kinds of requirements are not put into place in any anywhere in the law. And the result is, you know, nursing homes operate for profit. And your biggest, you know, so maximize revenue, minimize cost. Your biggest cost are the labor costs. So the less staff you have, the less fewer your costs, and the more profit you have, and

Susie Singer Carter:

So, profit as opposed to patient's profit ahead of the patients really.

Rick Mountcastle:

Correct. Yes, that's just that's the system. Okay. Just so I'm sure that you're the the caregivers listening to this podcast, who have dealt with their loved ones in a skilled nursing facility have seen that have seen the chronic understaffing and, and, you know, in my mother, I was in rehab in a skilled nursing facility that was reputed to be very good for, you know, I guess it was maybe around 85 or 90 days. And it was, and you could just see the chronic understaffing and I felt really bad for the certified nursing assistants, the CNAs, were doing their best for the, you know, the LPN, the licensed practical nurses who are providing the hands on care. They're doing, they're trying their best, but when you're understaffed, and you've got, they've got call bells going off all over the place, there's only so much they can do. Okay, and, you know, maybe things are getting better now. But the CNAs, who are actually taking cans on care of our loved ones in skilled nursing facilities are paid a pittance for what they do.

Susie Singer Carter:

I stay very close with the CNAs that where my mom's at, and I feel very compassionate for them. And especially now during the pandemic, it's and we've had a surge in the past couple of weeks here, in at least in Los Angeles, it's been rampant. And every day, every day, it's now increasing where it's, we get we get text messages and phone calls that say, another 10 staff members have been sent home another, another 12 staff members have tested positive I don't know how they're going to handle it if it continues. And and I don't know who steps in at what point what if, I mean, I just don't know what's going to happen. I'm panicked about it. And and I talked to my mom's the nurse that sets of our zoom calls, because we can't visit our loved ones now. And and she is exhausted. And you know, there's the face people, there's the face behind all of this disaster. What do we do about that? Who how do we? How can we as caregivers step in and make noise and make change?

Trish Laub:

So Susie, I want to take that and tag on to go back to something that Rick talked about, because I really experienced the way that the medications get exactly as you described a nurse observe something calls a doctor that rubber stamps it. And then it just compounds. And I think that I mean, I will tell you at one point, my family told the nurse on duty that my dad couldn't have a certain medication, she literally looked at me and said, Well, what do you want me to prescribe for him? And I looked at her and with every ounce of kindness I had, he said, I don't remember getting a nursing or medical degree like, how am I that's what you want me to tell you what medication, but I think for the people who are listening, as Susie mentioned, yes, caregivers are already overwhelmed. But I can tell you from my own experience, if you have somebody in a skilled nursing, whether it's rehab or or a home, one of the most valuable and important things you can do is be a patient advocate in regard to medications because once that cocktail of many different medications are put together, then you start having all these other symptoms and behaviors and everything else. My dad was in skilled rehab, it was supposed to be five days it ended up being 63. And there were four distinct times when he was given the wrong medications and it almost killed him. Sure they hung IV bags and this all goes back to the fact that there's so grossly understaffed, but as a family member, before they gave him a mad, or they gave him an IV, we checked it. Because four different times the medications I gave him would have killed. And you know, it's just it's a catch 22. But what the caregiver can do is learn to be a patient advocate and look at those meds and look for those blackbox warnings.

Susie Singer Carter:

And what do you do, let's say, you know, we, we discovered that this kind of thing is going on, but regardless of the reason why we all know, there's there's legitimate reasons, what can we d...?

Rick Mountcastle:

You're talking about in the big picture, kinda?

Susie Singer Carter:

Yeah. Yeah. Ages, we need to make some changes. I mean, I literally made a video for our governor during, like, during the COVID. But at the time, and I was like, I put together the most compassionate, tear jerking thing, you know, trying to get his attention. Anyway, you know

Rick Mountcastle:

You know, so? Yeah, so I guess. For me, my that... personal opinion is that the understaffing is the root of so many problems and come up into in skilled nursing facilities. And so there's got to be a coming together a coalition, some sort of a movement by caregivers, okay. As the voice for their loved ones who are having to live in skilled nursing facilities, to to get the states to require a specific minimum level of staffing. You know, I don't know that I've, I've been looking at skilled nursing facilities probably for eight or nine years now. I don't know that there's any kind of group that is really out there pushing for that. I've not seen that. But, again, my personal opinion from what I've just seen, anecdotally is that, you know, the things that government regulators look for in skilled nursing facilities are pressure sores, you know, lack of nutrition, dehydration, all those things, those things happen because of understaffing. There's not enough time for the staff to properly feed, those who need to be have helped feeding, there's not enough time for the staff to make sure that, you know, they're getting sufficient hydration that they've got the drinks that they need. And hygiene and hygiene, yeah, clean, clean, making sure they're clean. Dealing with incontinence. You know, there are, you know, I hear stories now, where there's complaints being made about a loved one who basically said in the urine soaked in urine, so close for six hours in a wheelchair. You know, you know, my reaction to that, because of the work I've done, and it's very sad. Is that just a normal as a normal day in the life of somebody in nursing home, and that's really sad. And that's because they are understaffed. Okay. And until there's outrage, okay, by that's expressed by caregivers, by family members, that they express that outrage to the state legislatures, to the state government, and demand that that standards be put in place that skilled nursing facilities have to follow in terms of how many staff the staffing ratios until staffing ratios are there that they have to follow? Then nothing's going to change.

Susie Singer Carter:

Right, right. Yeah, no, and it's so bad, I'm sure you've heard of this, where there's, there's people that they can't, they can't afford to be in a nursing home, they can't afford to be in assisted living, and they'll go to a hospital for some treatment that they need. And then they're put out left somewhere, someone with dementia is just left on the on a corner. And we are, we are a terrible society in that we don't take care of that. And, and, and we, you know, if we don't see it, it's not there. And that's, that's unfortunate. That's unfortunately what's going on. If you know it's the blind guy and and that's what's happening. You're so right. This is why Trish and I are talking about this why I have this podcast. This is why I've just become an official caregiving.com champion because I'm out there wanting to be you know, amplify this, this this crisis. It's a crisis.

Rick Mountcastle:

And it's getting worse. So think about this back this pre COVID Okay, you had at least the, the, the nursing home or the skilled nursing facility residents who had family members that could advocate for them. They had that right. But there have always been a group who are in those nursing facilities, particularly the ones that are funded by Medicaid, you know, you're less economically advantaged folks who have no one. I mean, I have seen cases over and over again, where so and so's been in this nursing home for years, and they don't have a family member that comes to visit them. And that is just, that's heart wrenching. Right. And consequently, their care is the worst. Because there's nobody advocating for him. Now with COVID. Nobody can get in. Nobody. And so yeah, yeah.

Susie Singer Carter:

And you know, how many peope have died?. They've died from being isolated. Not just, you know, an anecdote, it's science. You can't people can't survive being isolated.

Rick Mountcastle:

Right. Plus, you think about how when the caregivers the family members were able to get in and how much they did, right, they wouldn't fetch the drinks, they went and checked and made sure that the food was eating properly, because they knew that the staff there was did not have the ability to do that because of understaffing. So now more than ever, when those family members who were supplementing the paid staff by taking care of their own loved ones, now more than ever, when those folks cannot get in, there's a need for adequate staffing ratios to be put in place and mandated to the skilled nursing facilities and these, particularly the corporate ones, right? Those are the biggest offenders.

Susie Singer Carter:

And reaction is not a solution, we need to put plans in place, because we're already understaffed. And now we have a pandemic that is making that 10 fold. Right, so what is going to happen, and even if you didn't go in and be a an assistant caregiver, hands on with your parents, the very fact that you could drop in at any moment keeps people on their toes. So that again, back to the big picture, what where do we go, we have our coalition now, what do we do?

Rick Mountcastle:

All right now, now we need to start advocating to the state governments, particularly in the individual states, to put in place staffing ratios. That makes sense. So I guess, part of that is maybe consulting with a skilled nursing facility experts, you know, to say, Well, how many CNAs do you need per every 10? Or every 20? Residents in a skilled nursing facility?

Susie Singer Carter:

We do an education we do that? Children, right, we say how many teachers per student?

Rick Mountcastle:

And if and how many do you need for a dementia ward? Right? Because they need more care? Indeed, I don't know my sense. I don't, maybe I'm wrong. But my sense is that from a corporate level, the skilled nursing facility staff dementia wards, just like they staff the rest of the facility. And so, so I think part of it, and I don't, you know, maybe this is your show, here's where this gets kind of put together, is getting some experts to help. Gosh, I can't believe that this has to have been done at some point, somebody has to have looked at this because this problem has been in existence for a long time. But come up with a what constitutes a reasonable rational staffing plan based on a patient kind of mix to pick, you get these kinds of patients in these skilled nursing facilities? What are the different kinds you get there? How much care does each each one of those get need? And then come up with a plan for how the place should be adequately staffed?

Susie Singer Carter:

Absolutely. And when a family member is identified at different stages of their of their disease in terms of dementia, but can I can I just assure you that you're charged more and if someone is incontinent, you're being significantly charged more for that kind of care. So no, so for in just in terms of economics, you know, that that should be addressed, and that if you're charging my family more for that service, then that service isn't getting done because you're understaffed that that's that's like that's a violation to me of services, right? If they're, if that's what they're charging you for. And you know, if it and we are we are, we're giving a budget towards that, so we expect it to be done. I mean, I think it until you get into this, this community and you really see behind the curtain what's going on, you assume I'm paying, I'm paying eight to $10,000 a month. Of course my parents or my husband or my wife is being cared for. They're not.

Trish Laub:

So, I was going to say, I think for people who are going to be faced with finding some sort of facility for a loved one, the patient to professional ratio is one of the first questions you need to ask, how many CNAs? How many nurses per how many patients? Right? I mean, that, to me is the critical question, but wide variance, too.

Susie Singer Carter:

But, even still, like where my mom's been at the very best in Los Angeles. And, and even then it's, it's understaffed to Rick's point is that the price for employees is their highest price tag. And so that's where they make their cuts the most. And I saw it, it's blatant, I don't know how any of the social workers can go in and not and not see the chaos.

Trish Laub:

Kind of moving a level closer to the patient from the overall it's some sort of coalition to change the staffing, let's say some, you have a loved one in a facility. And you think that things are not the way that they should be in regard to medications or treatment? What does someone do then? Where do they take that kind of complaint.

Rick Mountcastle:

So assuming you've complained to the staff there, which would of course be you know, to go to the front desk and want to see the RN on duty or LVAD, and you get no results, or if you're concerned about a medication that's being prescribed off label. And you're not getting that changed. So, you know, I thought about this before, and the place I think to go is the department, the State Department of Health, for two reasons. First, the Department of Health is usually and it may vary depending on what state you're in. But there's that's usually the state, the state agency that's responsible for inspecting and regulating the skilled nursing facilities, every skilled nursing facilities by federal law must be inspected on an annual basis. And so the inspectors are normally employees of the Department of the State Department of Health. So that's so they have that kind of jurisdiction, generally, that may be different in depending on what some of the other what state you're in. So you'd have to go and maybe look up, which state agency regulates skilled nursing facilities, but but that's one starting point. The other thing places to look at is if you have some concerns about how a physician or prescribers could be in I think, in many states, RNs can prescribe certain drugs, how that person is prescribing the the place to go if you can't get any kind of a response from that prescriber, or the the facility would be to the Department of Health Professionals, because every prescriber, whether they're a physician, or a registered nurse, or even a licensed practical nurse, are registered with and licensed by the state's Department, we call them Virginia, the Department of Health Professionals, not to be confused with the Department of Health. But a there's an agency that regulates how people with licenses, medical providers with licenses conduct themselves. And so the place to go there, if you can't get any kind of redress directly, would be to make the complaint for that state licensing agent. See, those are probably in terms of practical, those are probably the two practical places to go to, you know, of course, you know, HHS has their white 800 hotline, you know, waste fraud and abuse hotline, but you're calling a one 800 Number and either leaving a recording or talking to a call center, your results are going to be rather slow and cumbersome. You know, so you have to get it you have to get do it at the local state or local level.

Susie Singer Carter:

How productive is the, like adult protective services as adult protective?

Rick Mountcastle:

Yes. Adult Protective Services. That's another place. Yes, definitely.

Susie Singer Carter:

Social Services, too, I think because I know, as a conservator, they they come and do a report on a yearly basis, at least I mean, it's only a yearly basis, but at least you have that that person that that is assigned to you as a conservator that you can talk to and that, you know, their job is to make sure that the person that you are caring for is being cared for.

Rick Mountcastle:

Yes, yeah, I think they call them ombudsman in our in Virginia. But I think it's the same thing. So. So every state has that Adult Protective Service and conservator ombudsman position. They're a little bit limited in what they can do. But, you know, but some of them are pretty diligent. I've worked with some of those adult services, folks, and they're pretty, pretty good.

Susie Singer Carter:

Yeah, I had one that was very, very, very proactive. And, you know, was I liked it. I said, thank you. I enjoy. I enjoy you be grilling me. No, I liked it, you know, so? Yeah, I think you can find there's always a gem to find, you know, and I always say, make friends with those people that are that are helping you mate. You know, those are your those are your allies, right? I mean, it's, there's so it's so important to build a try, because it's really hard to do it alone. It's really hard.

Trish Laub:

You know, the situation with skilled nursing facilities, and especially with COVID, and everything, to me, that's one of the most shameful things our country has allowed. But I actually think there's something more shameful than that. And that's pharmaceutical companies that capitalize on our most vulnerable population. So kind of in that light, I don't think that you've covered what the result of your investigation into Depakote was what what happened with Abbott Labs, what what was there, I hate to say punishment, but kind of.

Rick Mountcastle:

I would call it punishment because Abbott Labs guilty. They pled guilty to a criminal charge involving what's called misbranding of a drug misbranding kind of being a legal technical term for basically promoting it off label, promoting it for us that was not approved, and doing a promotion for us without providing adequate directions for us based on that population. So they pled guilty to a crime. The company did penalty for that was a total of $700 million. The- the on the civil side, on, you know, the the whistleblower, part of the case, Abbott Labs ended up paying $800 million in penalties, and restitution to federal health care benefit programs, as well as I think maybe $100 million for violating state consumer protection laws. So it was a total of $1.6 billion in penalties. You know, and Okay, so I'm really this is definitely personal opinion, no individuals were prosecuted. I will say that our office, like in the Purdue case, wanted to prosecute individuals. And we were not allowed to do that by the Department of Justice. And I think that that is a that is a problem. A whole different problem. A whole different discussion for another podcast. Yes. About how we handle those cases.

Susie Singer Carter:

Yes. Yeah. We thought we had a little tiny like opportunity to talk to Rick beforehand, just to make sure because it's such a huge topic and that I had didn't bring that up, because I knew that's a whole nother that's a rabbit hole to go down. Right. Right. Yeah.

Trish Laub:

Now, was the if I remember, right, you said that Abbott Labs had a long term care division that was not necessarily. I'm not sure what word ethical. Did they have to close that down as a result of this?

Rick Mountcastle:

They did. They ended up closing it down? Probably during I think during the investigation. It was, it was? Yeah, so if you're only if you're not approved to market, your product, in nursing homes, for the treatment of agitation, dementia patients, it's pretty blatant to have set up a long term vision, just to do that in your corporate stru cture. Right.

Trish Laub:

That wasn't very subtle.

Susie Singer Carter:

No, not at all.

Rick Mountcastle:

So that Yeah, but the back that short, and that speaks again, probably probably topic for another podcast, it speaks to the the arrogance, I guess, and part it speaks to the feeling that, you know, the feds are so overwhelmed or not going to catch us anyway. It speaks to the even if they do catch us, you know, the penalties can be the cost of doing business and it's worth it because we're going to make so much money.

Susie Singer Carter:

a loss leader, in a way. Yeah. Yeah, okay. Well, I have to just say, thank you. Thank you so much. Oh, my gosh, God, damn it. You are you got a lotdone, Rick. You and Randy got so much done and and we can't You know, I can't thank you, I, you've inspired me so much to to continue on and because it's hard to like, you get exhausted, but you have to just keep remind remembering the faces behind why we're doing this. And I think that that, you know, those those are the reasons and those are the motivators and, and I love my mom so much. So I do this for my mom and everyone else's mom and dad that they love to and we love you, Rick and, and love is a big concept for us. Don always says-- he's not here. So I'm going to say it, "Love is powerful. Love is contagious, and Love Conquers Alz. And I want everyone to go out and if you want to be part of a coalition, let me know get in touch. We're here. We're ready to go. We're we're getting we're getting so revved up about it. So thank you for listening share,rate, and thank you again, Rick.

Rick Mountcastle:

Thank you.

Trish Laub:

Thank you.

Rick Mountcastle:

Yes, Susie and Trish. Thank you for all you're doing.