Moderator: Chris Marshall
July 20, 2010
2:30 pm CT

Coordinator: Welcome, and thank you for standing by. At this time, all participants are in a listen-only mode until the question answer session. Today's conference is being recorded. If you have any objections, you may disconnect at this time.

The PowerPoint presentation, PDF version, the audio recording of the teleconference, and a written transcription will be posted to the SAMHSA 10x10 Campaign Web site at http://www.10x10.samhsa.gov.

Our presentation today will take place during the first hour and will be followed by a 30-minute question and answer session, at which time you will press star 1 to ask questions. I would now like to turn the call over to Miss Leslie Brenowitz. Thank you. You may begin.

Leslie Brenowitz: Thank you very much and welcome everyone to the Safe Medication Use as an Essential Component of Wellness Among People with Mental Health Problems training teleconference. My name is Leslie Brenowitz, and I will be moderating today.

Today's teleconference is sponsored by the Substance Abuse and Mental Health Services Administration 10x10 Wellness Campaign. SAMHSA is the lead federal agency on mental health and substance abuse and is located in the U.S. Department of Health and Human Services.

Through an inter-agency agreement, SAMHSA's privileged to partner in this effort with the U.S. Food and Drug Administration Office of Women's Health, and we want to acknowledge the contributions to the Campaign and to this training teleconference, in particular, of Susana Perry in the Office of Women's Health.

The views expressed in this teleconference do not necessarily represent the views of the Center for Mental Health Services, Substance Abuse and Mental Health Services Administration, U.S. Food and Drug Administration, the National Institutes of Health, or the U.S. Department of Health and Human Services.

I'll also mention, again, that this call is being recorded for purposes of archiving it for others to use and if you have any objections to the call being recorded, you are free to disconnect at any point.

The focus of today's training is to share current research on the relationship between the use of medications, including polypharmacy. and wellness; inform you about the FDA's approach to managing drug-related risks; and discuss some of the trade-offs to be considered related to the use of medications to treat mental health problems.

The speakers on today's call are not in a position to respond to questions related to individual treatment plans, nor do they speak for their agencies or for the drug approval process, and I will probably remind us of that again before we get to the Q&A portion. But I do ask you to remember that.

Our first presenter is Jerry Overman, the clinical pharmacy specialist for the National Institute of Mental Health, part of the National Institutes of Health. He received his Doctor of Pharmacy degree from the University of Arizona and completed a post-doctoral residency and fellowship training at the University of Texas College of Pharmacy and the University of Texas Health Science Center at San Antonio.

He worked for 5 years as the clinical pharmacy specialist in psychiatry and substance abuse at the South Texas Veterans Health Care System and held a clinical faculty position at the University of Illinois within the Departments of Pharmacy Practice and Psychiatry.

His areas of interest include the pharmacological management of mood and substance abuse disorders and the deleterious effect of substance abuse disorders on other major psychiatric disorders.

Jerry will share with us some of the data on the actions and side effects of older and new generation antipsychotics as well as the impact of polypharmacy on the safe-use discussion. Jerry?

Jerry Overman: Thank you, Leslie, for that very nice introduction. My talk today will really focus on atypical antipsychotics and the health complications of atypical antipsychotics.

One reason being is that this class of medications is not only used in schizophrenia. There's a wide use now in the treatment of bipolar disorder, and in some areas, in the treatment of treatment-resistant depression. So I thought it would be an important class to go over.

I'm going to start the talk first just discussing a little bit about polypharmacy. You'll get a bit more from Dr. Weiss about some of the risk issues that the FDA evaluates. But as a clinical pharmacist and doing what I do—and when I entered the field of pharmacy was when one of the very first atypicals was first available on the market.

So there was this question of what is polypharmacy. And back then we would only be concerned about using a different drug from a different class. But now a days, with the numbers of medications being released onto the market, we kind of talk about the difference between polypharmacy and rational polypharmacy: Has the decision to use a specific medicine in addition to one that's already being currently used with a patient—how rational is that thought process, and do you choose one drug from one class being mixed with other classes?

We do know for sure that polypharmacy, whether rational or not, can increase the potential risk for medication related side effects, which is something very important for everyone to monitor, not just the physician, pharmacist, nurse that might be working with the patient but the patient themselves. In addition, increased risk of drug interactions.

And both of these side effects and drug interactions, it's important to realize if just, if there's—for the patient—if there's things that are, that they're feeling different, are they noticing more sedation than they were prior to the institution of a second drug?

The big concern is that these long-term risks really are relatively unknown and largely unknown compared to what the causal agent is. So, as clinicians, we tend to make sure to keep in mind the temporal relationship or the time that a second or third or, in some cases, a fourth or even fifth medication might have been added.

One thing that we know we can do to decrease risk is if we have better coordinated care. And in our health care system right now, we know that that can be a problem, having a provider who is a, and various different providers in various different clinics.

So that being said, I'd like to move into the idea of talking about the antipsychotic medications on the market. The slide you see in front of me, in front of you, lists the ideal antipsychotic. It's going to be a drug that has rapid onset of action, once daily dosing, very minimal, if any, side effects, no drug interaction, but it'd be safe in overdose.

But also that it's cost effective and hasn't, has activity in a range of disorders. And I think that's important when looking at the atypical antipsychotics, because some of the drugs that we used to use, the older drugs like Prolixin® and Haldol®, Thorazine®, really were effective in treating (excuse me) some of the positive symptoms of schizophrenia, but not so much the negative symptoms of schizophrenia.

And when I say positive symptoms, I mean those classic symptoms of hallucinations—seeing things that aren't there, delusions or paranoid behavior, and the negative symptoms being those symptoms that the patient, the things that a patient loses once the, with the onset of the illness—decreased motivation, decreased socialization, those type of things, in addition to cognition.

So really, this ideal antipsychotic, you could put this diagram for any drug out there for any treatment of any disorder, but for the, for specifically for what I'm going to talk about today with the antipsychotic, we really do strive to have minimal side effects, hopefully once-daily dosing.

The drug acts quickly and in a range of disorders as well as the safety in overdose. And again, as I mentioned earlier, these, this class of drug, the atypical antipsychotics, is widely used in the area of psychiatry.

So this table you see in front of you depicts the difference between the two different classes—the typical antipsychotics or the old antipsychotics to the left of the slide, and the newer or the atypical antipsychotic on the right hand of the slide.

In the next couple slides I'm going to go through both the generic and the brand names so not to confuse you too much. But I like this slide because it does give you a nice depiction of the two.

The typical antipsychotics on the left hand side would be those antipsychotics that really do tend to help patients with the positive symptoms I mentioned, but weaker with the negative symptoms. And the big issue with the typical or the old drugs were the movement disorders that you would have patients develop over time.

As I move towards the atypical antipsychotics, I'm going to talk briefly about some of their side effects. But just as the older or the typical antipsychotic had a very problematic side effect being the movement disorders, the newer atypicals have major health risks themselves. And one of those risks being the development of metabolic symptoms of side effects.

So if we were then to look just specifically at the names of those antipsychotics, so this slide depicts those antipsychotics that were on the left hand side, they block a receptor called a D2 receptor which, in addition to helping with the negative symptoms, also potently block the receptor that can lead to the development of movement disorders.

And it's for this reason alone you may recognize the term extrapyramidal symptoms. Some of those would be acathesia or internal restlessness, Parkinson's-like movements or dystonia of their large muscle contractions. Those were the really problematic as well as Tardive Dyskinesia for patients who were on these older drugs.

So the new class of drugs, the goal was to have drugs that helped with the positive symptoms but also potentially with the negative symptoms and hopefully without the same deleterious side effects.

So these drugs work by blocking both the D2 receptor, which I showed in the last slide, but also—and for the most part, blocking it less potently as the older drugs but also affecting a serotonin type receptor. And that's what that—the abbreviation is 5HT2—that's the serotonin type-2 receptor.

And the goal being help the patient decrease their symptoms, both positive and negative, and not develop the deleterious side effects. I've listed those—the drugs on the right both with their generic and brand name.

The last two on that slide, asenapine, or Saphris®, and iloperidone, or Fanapt®, actually were just most recently released on the market over the last year. We tend to have a little less experience with them just because their release has been so recent.

So before I get into the major health consequences for the atypical antipsychotics, we know for sure that immediate effects can occur both good and bad.

The bad side effects would be when a D2 blocker—so if you remember earlier on this slide, I listed the old typical antipsychotic blocking very tightly this D2 receptor. You can see the development of extrapyramidal symptoms, or EPS, and those were the names that I gave you earlier—the acathesia or internal restlessness, the muscle dystonias and potentially symptoms that make the patient almost look Parkinson-like, like Parkinson's disease. They move, they move very slowly, they have other odd movements.

And that can also, when blocked through another tract, can actually lead to prolactin increase. And the concern there is more with specific issues related to prolactin in breastfeeding, but that's something that the clinician will generally monitor.

The remainder of the side, of the receptors that are hit, in addition to what I mentioned earlier on the slide that showed how the drugs worked in order to have their good effect, are those receptors they hit to have the bad effects or the negative effects.

For instance, the histamine receptors are blocked can lead to sedation and weight gain. We see that with clozapine as an example, quetiapine, and olanzapine. All three hit that histaminic site so you can see why immediately patients can feel those side effects.

Another side effect of, when it hits a, when these drugs hit a receptor called the muscarinic side effect. And that's when patients might complain of dry mouth or urinary retention, decreased urination, blurry vision, constipation. They may get an increased heart rate or sinus tachycardia. And olanzapine is one example of a drug that can cause that, among others.

And then the last one is the Alpha-1 adrenergic side effects. And those were patients when they—their blood pressure dropped really quite dramatically that's called orthostatic hypertension. Maybe when they get up very quickly and they get a drop in blood pressure.

And, in particular, risperidone can cause the clozapine and quetiapine, again amongst others, but these are the side effects that happen pretty much when the, can happen when a medication has started.

Not every single patient that's on those medications I listed will have those side effects, but we can have an understanding why they might have those side effects relatively immediately when they do have them.

What I want to focus the rest of my time on is the issue of the major health concern of the newer drugs. As I mentioned earlier, the first issue here on the top left hand side is EPS. Again, that's extrapyramidal symptoms or movement disorders.

The old era of drugs—it was a major patient issue. Patients would have major, big problems with these movement disorders and to, and in the new era with the new atypical antipsychotics, it's less of a problem.

That doesn't mean that patients can't develop some of the movement disorders with some of the newer drugs, which they can, like acathesia or the internal restlessness, and some patients do get muscle rigidity, but it's not as big of a concern as it was in the past. Similarly, Tardive Dyskinesia is the same. A major long-term risk for patients on the older drugs, but it's much more rare with the newer drugs.

So the social issues, the cognitive issues and the vocational issues, we do really do have new hope and expectations with the newer drugs, in addition, the negative symptoms and refractory patients and also poor patient adherence.

And that's not to say that we don't have problems with the new atypicals. Any patient who's out there that may have been tried on one of these knows that one of the big concerns now is this cardiovascular health issues or glucose and lipid disregulation or weight gain. It's a major public health care concern. And you'll hear the term, specifically, metabolic syndrome.

So again, that's what I'm going to finish up with here with my part of the talk is that these newer, atypical antipsychotics, the ones on the right hand side of the slide I showed earlier and the second slide really have a, we have a concern with patients who've gained weight.

They can have increase in their triglycerides, their HDL. They can have problems with blood pressure and fasting glucose. And there's a definition for this problem, this metabolic syndrome, and it's more than or equal to three of the factors that are, exist, on this table.

So for abdominal obesity, it's literally measured by looking at the waist circumference. For men, that's greater than 40, for women it's greater than 35. For triglycerides we're going to want to have that to be greater than or equal to 150. For HDL, or you'll hear it termed good cholesterol because it can remove cholesterol from arteries, you want it, if the numbers are less than 40 for women or less than 50 for men, that can be a risk factor.

And I've listed there the blood pressure readings that we look at and the fasting blood glucose. So these are things we monitor as patients are on these medications.

There's a lot of information on this next slide. But what I really want you to take home from it is that if you look to the far right, it really does appear that the biggest problems with the atypical antipsychotics, when it comes to weight gain, is with clozapine, or Clozaril®, and olanzapine, or Zyprexa®. We do tend to see the most weight gain with those drugs. And then from that point, potentially more problems with cardiovascular health, lipids, triglycerides and issues with glucose.

And if you look at the far left, some of the other atypicals, the newer drugs, ziprasidone appears to have less of a problem with the weight gain, and then, potentially developing. The issue being, though, that the, all of the drugs in these, in the class of atypical antipsychotics, do have a warning for the potential development for these side effects.

So when we talk about weight, we generally talk about body mass index or BMI, and it's calculated by taking a patient's weight in kilograms and decreasing, and dividing it, by height and meters.

In obesity, overweight hits right at around 25 and then people are considered obese if the BMI is greater than 30. And I give you that definition just because I'm going to show you a couple quick slides before I finish up.

This is some data looking at the BMI. So, BMI on the X axis and the percent on the Y axis looking at what the acceptable rates of BMI. And if you look at the blue graph, that's schizophrenia and the green graph is that healthy controls or no schizophrenia.

And it's very clear that once you hit that, if you look at the X axis where it's 24 to 26, the BMI range, you'll not, you'll start noticing that beyond there the blue lines get taller and it really does appear that the issues with schizophrenia and weight gain occurs more with schizophrenia and potentially because patients are on these atypical antipsychotics.

Karen will talk a, more, about risk factors and modifiable risk factors, but this is, this slide actually shows data in, within the, healthy population. So, this is not patients, without, these are patients without schizophrenia but what happens with risk factors for heart disease.

All four of these on the, five of these on the left are single, modifiable risk factors. Weight can be decreased, smoking can be decreased, total cholesterol, development of diabetes, potentially, especially adult onset, and hypertension.

But if you look to the right, as those risk factors add up, it becomes exponential. And so as someone is smoking and overweight, you add to that total cholesterol greater than 220, which would be the second orange bar, the risk increases greatly. You add to that diabetes diagnosis in that hypertension and you'll see the risks go up dramatically.

Schizophrenia and diabetes is a big issue. I want to finish up with that. Again, diabetes is part of the metabolic syndrome. The prevalence of onset, adult onset, diabetes in schizophrenia is about 13 percent, and it does appear that that increased risk is actually before a patient actually starts taking an atypical antipsychotic. So there's thought that it might have to do more with the living situation the patient might be in or, et cetera. So there's actually a risk for the development of diabetes even before these drugs are started, which we know have a further increased risk.

And this slide just shows that as the BMI or as the weight goes up, a risk for diabetes comes, goes up, as well. And this slide looks at both drugs that we talked about earlier—clozapine, olanzapine, risperidone, quetiapine, aripiprazole, and ziprasidone on the left.

And the ones that potentially have a higher chance for causing weight gain, if we look at the second column, would be clozapine and olanzapine. Less of a problem with risperidone and quetiapine and even less with aripiprazole and ziprasidone, though when this was put together, there was a little less data on aripiprazole and ziprasidone, though we do see that those risks do tend to be decreased for those two drugs.

Same with risk for diabetes and same for worsening a lipid profile when we talked about cholesterol, et cetera.

So one thing that we can do—and I'll finish up with this slide—is make sure to monitor for metabolic syndromes when patients, before they start medication and then as they as they're on medication so you can see at baseline before a patient starts the medications.

You get a good personal family history. Is there a history of diabetes, et cetera? You want to get a weight or a BMI, a waist circumference, like I mentioned, as well as blood pressure, fasting plasma, glucose and lipid profile just like I mentioned in the earlier slide.

Then at monthly intervals you want to keep a definite check on weight and see if weight is increasing or decreasing and then if it needs to be addressed. At 3 months, then, you also look at blood pressure, glucose, and lipids quarterly, again, the weight and then annually.

Check in with the family, make sure there's no new things that have come up, and again, waist, circumference, blood pressure, fasting glucose. And then every 5 years make sure, at least every 5 years, to get a fasting lipid profile. So with that, I'll hand it over.

Leslie Brenowitz: Thank you, Jerry. Very informative and very interesting research that we're starting to see on the impact of taking various antipsychotics on physical health and certainly a lot of the things that need to be part of the consideration when someone is looking at a treatment plan.

Our next presenter is Dr. Karen Weiss, who is the lead for the Safe Use Initiative in the Food and Drug Administration's Center for Drug Evaluation and Research. She's been with the FDA for 20 years, during which time she's been involved in a variety of activities, including regulation of therapeutic biologicals, pediatric drug development, oncology drug development, and now drug safety.

She received her undergraduate and medical degrees at the Ohio State University, completed a pediatric residency in Grand Rapids, Michigan, and a pediatric hematology oncology fellowship at St. Jude Children's Research Hospital.

Prior to joining FDA, she was an assistant professor at Georgetown University, and she earned her masters degree in public health from Johns Hopkins University.

Today she is going to share with us the FDA's approach to medication-related risk and harm reduction and the collaborative opportunities that exist within the agency's Safe Use initiative. Karen?

Karen Weiss: Okay. Thank you very much, Leslie, for the introduction, and hello to everybody out there. And it's a pleasure to be able to be here and to provide this webinar.

I must say that, as was mentioned to Leslie, it's a little bit daunting to give a webinar and not be able to actually see and interact with your audience, which I much prefer.

I, as mentioned, I'm primarily going to focus my remarks on our Center for Drug Evaluation and Research's relatively new initiative that's called Safe Use. And Safe Use is really all about developing collaboration to try to reduce preventable harm for medications.

And even though my talk's going to be in the most part, general, I will try to give some examples from some of the specific medications that are used in the area of mental health.

So to start with, this is what I call my yin and yang of medications. And I'm probably taking a little bit too much liberties with the ancient Chinese philosophy, but I wanted to convey—and I think, actually, Jerry conveyed it very well—the fact that all medications have their good effects and their negative or bad effects.

And of course, this visual, as it may be, exactly the ideal because the ideal medication, as Jerry I think shared in one of his earlier slides, is really one that has very few, allegedly, no risks. And even though that's the ideal, we know that isn't always the case, unfortunately. And the goal, though, is to really try to develop and utilize medications that maximum its benefits and minimize its risks.

And when we talk about risk from medications, and you've heard a lot about them in the previous slide from the previous speaker, you can divide them up into two broad categories of risk.

The boxes on the right depict the risks that you can't really avoid. And those are things like gaps in our current knowledge about the drug and its profile. Oftentimes, when a new drug comes to market, even though it's been, it's usually fairly well studied in clinical trials, the clinical trials can never be large enough or long enough to really uncover all the potential adverse event profiles of the medication.

And so, it usually isn't until a drug is out there on the market and put into wider use that rare events may come to light, things that one wasn't even aware of until its—larger populations—are exposed to the medication.

Also, clinical trials tend to be fairly controlled kinds of settings and appropriately so. You want to control for all sorts of variables to make certain that the effects of the drug, both good and bad, are really isolated. And so the clinical trial scenario is, in many ways, somewhat artificial.

And when something is out there in the real world being used, there may be individuals, populations that use the medication that are on concombinant— other—medications. Dr. Overman mentioned the polypharmacy arena. Sometimes there are interactions with other drugs or other foods or botanicals or whatever that may not actually have been fully evaluated in the clinical trials.

Or the people that take the medications maybe had various co-morbid conditions that hadn't been fully evaluated and tested in the course of clinical trials. Or there are rare events, things that occur in maybe one in 10,000 individuals or one in 100,000 individuals and the clinical trials can usually not be, are usually not large enough to, uncover those kinds of events.

So those are some of the gaps in knowledge that may lead to adverse events or harm that you don't know about so you can't really avoid it until you actually know about it.

And then sometimes when medications are studied and well known and even used as optimally as possible, there are certain events that you just can't avoid, you can't really reduce them, you can't really minimize them as hard as you try.

In my previous life I was an oncologist in the pediatric realm, and chemotherapeutics are notorious for causing quite a number of adverse events. And I think the same goes with a lot of the psychiatric medications that are in use now.

But then on the other side are the preventable risks. And that's really the goal of our Safe Use Initiative, to try to get to the harm that can be minimized or hopefully prevented.

And those are the kinds of things like accidental or unintended exposure, like children getting into medications and overdosing or by inadvertently overdosing in medications because, as a consumer, one isn't actually aware of the active ingredient, wasn't aware that there are—they're taking multiple medications that actually have the same active ingredient.

There are areas where individuals actually will misuse or abuse medications. And that clearly is a big issue in the population that has suffering from some of the mental health issues.

Sometimes there are quality defects in the actual manufacturing processes, and then sometimes there are what's called as frank errors. Things like making a mistake in dispensing the medication, dispensing the wrong medication, giving the wrong dose or at the wrong time or the wrong route, et cetera. Those kinds of things. Those are all kinds of preventable harm that our initiative hopes to try to minimize.

On the next series of slides I just have some graphics, and maybe somewhat again of a—of an easier misrepresentation, but to give an idea of the balance that we have with medications including—to set the risk and the benefits.

So at the time that a drug, a new product, comes to market, we have its known efficacies usually uncovered through the course of its clinical trial, and then there's specific risks that have been identified in the clinical trials.

And some of those are the unavoidable ones, the adverse events that we've, that just have been covered in the clinical trials, and some of them might be able to be prevented, particularly if we know about them and can actually direct the health care providers or the consumers to monitor certain things.

Dr. Overman mentioned some of the issues about the metabolic syndrome and monitoring some of the weight or monitoring certain types of parameters to assess that potential risk. Or one example, Clozeril® that was mentioned earlier on as being one of the earlier atypical antipsychotics, it was known fairly early on that that medication leads to a potentially very serious adverse event where the white blood counts are quite dramatically reduced.

And so early on, actually at the time that the drug was approved, there were specific provisions in place to actual require patient monitoring. And unless the patient had blood counts and was monitored appropriately, they could not get the medication. And so those are things that are—it's a risk, but we can try to prevent that by instituting specific types of monitoring.

And then as exposure increases, if the product is out there in the marketplace, more risks become uncovered. Some of them are unavoidable, some of them might be able to be prevented, but it tends to start to shift the balance perhaps a little bit.

And then as exposure increases, and there's more use in the marketplace, there is more of a tendency to misuse the medication, to, for errors to occur. These kinds of things then start to also shift the balance, and it might actually shift it to a more unfavorable type of risk benefit ratio.

What FDA does, certainly at the time of marketing and then as part of its post-marketing surveillance, is to continually assess a drug safety profile. And FDA can impose specific types of activities, has specific authorities to do things that will hopefully again shift the balance towards more of a favorable ratio.

And some of the specific FDA interventions could be requiring stronger warning on drug label. For instance, many classes of medications used in the - in mental health carry box warnings to warn the prescriber and the patient about very specific, serious risks.

FDA can also require specific types of strategies called risk evaluation minimization strategies, abbreviated REMS, that require the manufacturer to develop specific programs for, and providers to get specific training, perhaps, to also try to minimize risks of medications.

These are all specific activities that the FDA can do when faced with and evaluating and coming to grips with additional safety issues from its regulated medications.

And then finally, our particular initiative, the Safe Use Initiative, hopes to employ additional interventions that are non-regulatory in nature, which I'm going to describe in the next couple slides, but will hopefully then further shift the balance again towards a more favorable benefit risk type of assessment.

So the Safe Use Initiative is FDA's non-regulatory activity to reduce the risks or preventable harm from prescription and over the counter medication. And we developed this initiative because we know that our regulatory authority alone is not sufficient to prevent harm.

And in fact, much of the use of medications, much of the harm, comes after a product is marketed and is out there on the marketplace. And it comes from decisions and errors perhaps in prescribing medications, it comes from errors in dispensing medications, it comes sometimes from misunderstanding about how to appropriately take the medications, sometimes health literacy is involved in that type of issue.

And so there are a number of places where we think this initiative can actually play a role in improving medication safety. And the way we want to do this is by partnering with all of you out there in health care. So providers, insurers, consumer groups, professional societies, all of you who could actually work with us, and we with you, in controlling, modifying, influencing behavior and practices to improve the safety of medications.

Now I just have a side-by-side to show some of the activities. I think I've already provided much of this information. The activities that can occur on the regulatory side, things like requiring new warnings, issuing guidances, bringing important drug safety issues to an advisory committee, requiring the REMS programs, like I mentioned.

On the Safe Use side, it would be different kinds of activities. It would be convening stakeholders who have a vested interest in a particular drug or class of drugs to discuss barriers to the safe use and to work together to develop interventions that can then actually be put out there in the community.

It would also involve developing maybe more formal public, private partnerships to put in place interventions and to measure the impact. And there are many other types of activities that we think that we can do in this voluntary way to try to mitigate the harm from all regulated medications.

And the priorities we want to have for these activities, we want to be able to identify drugs that are associated with preventable harm that have a big public health impact that are amenable to the collaborative approach that one can measure the impact. And if we have regulatory activities that are already ongoing, this initiative would hopefully complement those regulatory activities.

And so, I just have a couple examples of a couple areas of drug or drug classes where I think it would be very right for potential collaborative type of activities with the FDA, with SAMHSA, and potentially many other partners in this endeavor.

And two of them have to do with medications that tend to be problematic because they tend to be misused and abused. And one of stimulant medications and stimulant addiction. We know this is a growing problem, particularly among our younger population. And understanding why this occurs and understanding how to actually reach this particular population I think would be a very relevant safe use type of activity.

Similarly for opioids, there's a lot of activity already going on in the Center for Drugs to try to develop programs under the regulatory side of things to minimize the misuse and abuse that occurs with opioid medications, particularly certain classes of opioid medications.

And again, we believe that a Safe Use strategy of developing partnerships among health care to develop education and outreach and other types of activities can actually go a long way to complement our regulatory activity.

And then, finally, on my last slide, just the whole area of the psychotropic medications, the atypical as well as the typical medications that Dr. Overman talked quite a bit about, these all have important benefits but also quite important and serious side effects. And working in partnership with the community that prescribes them as well as those that actually have to take these medications to try to encourage, optimize, and optimize use I think would also be an important partnership as part of our Safe Use Initiative.

And on my last slide I just want to reiterate that I believe there are many opportunities for our FDA Safe Use Initiative to develop partnerships to improve the health and wellbeing of those with mental illness. And I look forward to ideas and partnerships as we move forward in our initiative. Thank you very much.

Leslie Brenowitz: Thank you, Karen, very much for letting us know what FDA is doing now in the area of Safe Use and how others can get involved on the non-regulatory types of activities. Obviously, it's an issue that needs input and participation from all aspects of the system.

I'm pleased to present our final presenter, Mark Davis, who is a leader in the mental health consumer/survivor, suicide attempt survivor, individuals with disabilities, and sexual and gender minority communities, and he has inspired the development of more than 75 peer-run groups in cross-system collaborations.

Mark has used his own experiences, as well as his skills as a public speaker, to promote social inclusion, inspire others in similar circumstances, and affect change in both the behavioral and mental health systems.

He is the founding president of the Pennsylvania Mental Health Consumers Association, and he facilitates Pink and Blues, a depression and bipolar support alliance peer-run recovery support and advocacy group for persons living with mental illness who identify as LGBTIQ.

Mark will provide his perspective on the main effects and side effects of medications from his own consumer/survivor point of view. Mark?

Mark Davis: Hi, everybody. Thanks to those responsible for putting on today, and welcome everyone to the call. I think everybody looks marvelous, and I wish we were in the same room at the same time, but we'll have to do with this technology.

I'm going to start by introducing myself the way I do every week at the Pink and Blue support group in Philadelphia's peer-run recovery group where we can have a safe place to explore our dualities as sexual and gender minority citizens and also the conditions in which we live and we can be ourselves.

It's a free group with no government or foundation funding, and the—it's state-based and it's not affiliated with a church, but the space is given to us by St. Luke and the Epiphany, which I applaud for their efforts.

We're actually not a DBSA affiliate group, but we're aligned with peer-led recovery principles. Each week, we introduce, name, sexual, or gender identity, our conditions, and something positive to, not, so we don't focus on what's wrong with us, and we get into the mindset of recovering and living with whatever our conditions are.

For me, I'm a proud gay asexual man. I'm living with bipolar II, and I call it the sequel. I'm in recovery from additions to cigarettes, drugs, and alcohol, and have been living with HIV since testing September 27, 1988. I'm profoundly deaf in my right ear, and the ear I'm using the phone is distorted, but the profoundly deaf ear is the one where I have the ringing. And I am a suicide attempt survivor. So, that's a sample introduction.

I'd like to say, in the forecast today, it said stormy from the Northeast to Montana high plains. So buckle your seat belts. It's going to be a bumpy ride. And right now, it's always sunny in Philadelphia.

So on the positive note, Betty White says she's 88½. I'll say I'm blessed to be in the right place at the right time and with you today to be active in the mental health consumer survivor civil rights movement for 25½ years.

And I have to put a plug in for the Office of Mental Health Substance Abuse Services in Pennsylvania for taking bold steps to include sexual and gender minority culture in affirming services through recommendations driven by the community and the formation of the Keystone Pride Recovery Initiative. And you can find that at http://www.parecovery.org. And it's under statewide initiative and behavioral health services for lesbian, gay, bi-sexual, transgender, questioning, intersex people.

Next slide. So I Am Who I Am basically isn't about me. It's about all of us. We are who we are. And I'm not sure if the slide was changed to say that we are people first and we're living with, and sometimes we're suffering from, and we've been addicted to or in recovery from. And we're not our diagnosis and we're limited by, we're able to, and we are who we are.

And so I put in some songs from Gloria Gaynor to stress the importance of naming it, claiming it, taming it, framing it, singing it and dancing it. July is Mad Pride Month and also Bebe Moore Campbell National Minority Health Awareness Month. So I wanted to put a plug in for that. Next slide.

This is about multiply-occurring conditions. Throughout history we were labeled co-morbid to dually-diagnosed to double troubled to co-occurring when in fact many of us are multiply-occurring with a variety of conditions that all impact on each other. I had allergies as a child, so everything old is new again as an adult. And I'm just hoping we could see this for what it is in that - and we now can agree we are people first from multiply-occurring conditions from diverse demographics and environments.

Basically, we're holistic unique and fabulous people needing help with the most basic of human needs and partnership to find an array of recovery-based community services to address those multiply-occurring conditions. Next slide.

This lists the main effects and the side effects. And I have a lot more on my slide than you do, so I guess it's TMI—too much information—but I'd like to point out that sometimes opposite effects occur.

Like the time I was pushed into a manic state from taking a side effect medication for HIV. I call it “stool so soft.” And I think truth in advertising, you know, there's—pharmaceutical companies would be great to put out dispensers, you know, toilet paper dispensers for truth in advertising because that's a real issue for many of us.

I'm proud to be an alumnus of the community mental health system, a survivor of shock treatments and homelessness. I've had unique things like the fifth disease and gout and pleurisy. Well, unique to some, but not to others. And I survived a hate crime with traumatic brain injuries that were after-effects, not immediate affects, and trauma from growing up in Urbana, Ohio. Not the town itself, but in a heterosexual world.

And it has not been safe to be gay in the mental health services nor diagnosed in the gay culture, thus, living in duality akin to “don't ask, don't tell,” depending on who we are with. And that's why the Pink and Blues is a safe place to be our dualities. Next slide.

So, this is what I live by. It's not an official model that's been published. And so maybe I need do that next. But it's what helps me frame what I'm trying to do on a daily basis to live in recovery and to be happy. And it's everybody's acronym and everybody's philosophy put into five simple categories.

You know, medical, what do I need to do medically involving medication, what do I need emotionally? Is that peer support, or a psychiatrist or psychologist, social, you know, outside in the community with peers, spiritual, that really impacts on our recovery. And I add the third as sexual, which for me, being asexual, is silent. But we never talk about the condition of human sexuality, and we all have one.

And it's important to focus on health to include, you know, our sexuality and to include that in the midst. So I consider myself a mess, and every I'm cleaning up my mess, and, or I'm doing housecleaning. And I also believe that humor is the best medicine because there's no co-pay. Otherwise, I could not afford to participate.

Next slide. This is put here to illustrate that I don't speak, I speak for myself, but I speak broadly for a variety of different people coming from a variety of different perspectives. We are diverse in our affiliations, ideology, our strengths, and we're bonded together to live happily ever after.

And so, that's been a debate as to how to call us, what to call ourselves, and it's been nailed down to a consumer/survivor movement. But there are many ways that people describe themselves and live by. Next slide.

This is about the main effects, also known as side effects. What came first? The condition, or the side effect? We just learned in the news that the chicken came first, so hopefully we'll learn more about our roots only if we look a little deeper.

Finding the right medication is like finding needles in a haystack. And we really miss the roots of our trauma that we've experienced in our—throughout our lives, whatever that is.

I was on AZT early when I first tested positive and made the choice to go off. And right now, as we look back, that was a very toxic every four hours 200 milligrams. And literally, we carried beepers to wake ourselves up.

Lithium toxicity is a problem. Many people have had transplants, and so there are the risks and dangers that people need to know about and—because it's our bodies. I took lithium and I'm not going to say it's good or bad for anyone else other than I felt like I was on mute or hold and there was a fine line between creativity and madness.

There's a lot of stigma in the name of medication when Wellbutrin® is used in psychiatry and renamed as Zyban® for smoking cessation. And in graduate school—I was lucky to graduate before the majority of the mental illness hit in my life—that our behavior equals the function of the person and the environments in which we live. Next slide.

So these are really two important distinctions that I've experienced between the mental health system and the HIV world. Living as a person with HIV I've experienced informed consent, encouraged, educated, and supported to voluntarily take an HIV cocktail combo with an emphasis on adherence, whereas in the—living with a psychiatric diagnosis—the tone is punitive, restrictive, involuntary, with a prescribed focus on compliance. Huge differences.

There are models in the pharmaceutical industry that hire people living with HIV that can be duplicated for people living with other multiply-occurring conditions.

You know, we are the experts of our body and our value to work within to affect change from without to increase our life expectancy. It's, you know, an epidemic when we've died 25 years too young. So I feel like I'm living proof, experiencing both systems.

I just heard someone say that then in the context of terrorism we went from a cold war paradigm to a bipolar world. That hurts. You know, in the headlines there were diagnosed with people with medication as have, you know, with mentally ill or off our meds or inappropriately diagnosed or “that person couldn't have committed that crime because it was too sophisticated for a crazy person to pull it off.”

We see pharmaceutical ads everywhere in coupon sections, discount ads. And when the American Psychiatric Association was in Philadelphia, cab drivers had receipts with the medications on the back. One of my magazines is, it has 24 pages of ads and they're 50-page magazines for HIV. So I applaud Rosalynn Carter for the work she's doing to train journalists to get it right in the media. Next slide.

The politics of mass prescription, you know, it really posed questions for me that I don't have the answers for. You know, we passed parity. Where is the parity? When the discussion occurred about health care, where was the focus on mental health addition, suicide prevention, and co-occurring health issues?

And what is the future of early recovery intervention community mental health addiction, holistic health, and suicide prevention? And will the DSM5 do no harm in properly diagnosing and better understanding how to treat people with multiply-occurring conditions?

I came up with the phrase “no child left on drugs.” It happens to elders and it really, you know, and I just heard that this generation is predicted to live shorter lives than other generations have before them. So it's, you know, it is a crisis. Next slide.

Basically, you know, I'm posing, you know, more questions of, you know, the struggles that people have. And I'm very appreciative of the AIDS drugs assistance programs. My four medications total $44,000 plus, and together, everything is almost $67,000. But, you know, no pain, no weight gain, which really, really, really, really is a problem.

And I was on a—I'm on 18 prescribed medications—and one time, I was on three from HIV that began with V and I tried to turn it into a positive, “victory over this vicious virus,” as I head into my 22nd year of knowing I'm living with HIV.

So I'm trying to think (let's see I was) the cost factor. So really, you know, it's “act up, act out, act now,” that we really need to mobilize, and everybody is responsible. It's not pointing fingers at any one person, group, or entity. We're all responsible for the solution and saving lives. Next slide.

So it's not about us without us and, you know, I can speak for myself that we need to be at the table, equal participation with our allies working together for solutions. You know, the stigma equals discrimination and reasonable accommodation is their quality.

Silence equals death and knowledge does equal power, so heed caution. And, you know, we need to come together on this to collectively—the mental health consumer/survivor movement is getting older, heavier, and more disabled, and we need an infusion of youth.

And I would be remiss not to include and mention the National Suicide Prevention Lifeline that you can find in your telephone books under 911, but it's 1-800-273-TALK as a resource to find a 24/7 live person to talk to or whatever it is that works for you because we really don't understand, like, being depressed, taking an anti-depressant, having energy, feeling better, but having the energy to possibly attempt suicide because we're so depressed and sad.

People need to understand what that really means in taking a medication that ultimately, hopefully, will work for the good.

So all of this is to honor my sister, Jennifer Ann Yokum, who died by suicide in 1995, and three peers—Lane Wilson of Pittsburgh, Stefan Hobbs of Philadelphia, and Donna Wagner of Danville, Pennsylvania. All three died suddenly during the 20th, 21st, and 22nd annual Pennsylvania Mental Health Consumer conferences.

A harsh reality of people with mental illness dying 25 years too young. Yet, they were dancing and celebrating with peers, and they will forever remind us of this call to action during this epidemic.

The next slide has some resources. Pat Deegan's—the information about personal medicine. I highly recommend everybody read Mad in America and Robert Whitaker's new book Anatomy of an Epidemic: Could Psychiatric Drugs Be Fueling a Mental Illness Epidemic?

Other resources included from, further information, and so I, you know, thank you very much and look forward to the question and answer phase. And I'll say you all look great and thank you very much and I wish you a recovery life for whatever it is you're living with.

Leslie Brenowitz: Thank you, Mark, very much, and really giving us some insight and embodying those kinds of decisions that need to be made regarding treatment and wellness and prevention throughout life.

We are going to move on in just a moment to the Q&A. I'll just point out that the next slides, slide numbers 52, 53, and 54 present some other resources available on making decisions about mental health medications, clinical trials, all of the FDA Safe Use Initiatives and other resources as well as some other resources related to shared decision-making and harm reduction related to mental health medications, and then biographies of our speakers as well as contact information, should you wish to follow up with any of them following the call.

We're now going to move on to the Q&A, and there are two ways that you can ask questions. One is by pressing star 1 on your phone and you'll be placed in a queue, give the operator your name. The operator will announce your name when it's time for you to ask your question, so if you do not wish for your full name to be announced, then please only state your first name.

Additionally, you can submit questions using the Q&A tab at the top of your screen, and we will field as many of your questions as we can. And if we are not able to get to your question, I'll let you know how you can get in touch with us and ask a question after the fact.

So, Operator, if you would please, let us have the first call.

Coordinator: Okay. Once again, I would like to remind you, star 1. You do not have to give your full name. Just state your first name at the prompting, making sure your line is open when you do so. Once again, it is star 1 to ask a question.

Should for some reason you need to withdraw a request, that is star 2. And, ma'am, it only takes just a moment for questions to come through, but I have one standing by. Please hold. (Chris Norton), your line's open. Go ahead, sir.

(Chris Norton): Hi. I am a psychiatrist. I'd like to thank all three presenters for this excellent and informative presentation. And my question is sort of an appeal for information.

A lot of us psychiatrists who are becoming aware of the terrible health disparities that people with mental illness face and the role of medications in some of these health disparities are very interested in thoughtfully and carefully helping people reduce or eliminate medications. And yet, I have found it very difficult to find guidance in the psychiatric literature for that process.

For example, in the slide that you just showed, there's a marvelous resource from the Icarus Project, but that those guidelines were written by consumers. And as wise as they are, it would be awfully nice if there were a clearinghouse of some kind for psychiatrists to be able to help one another with this very critically important project. Do you have any advice or thoughts on this matter?

Leslie Brenowitz: Jerry or Karen, are you aware of resources in the clinical literature that would support and help psychiatrists and consumers in making these kinds of decisions together?

Jerry Overman: This is Jerry. And I, if I'm hearing correctly, the question is really about when you're trying to fine-tune the meds and potentially get rid of meds or switch off how to go about transitioning. Is that what I'm, is that...

(Chris Norton): Yes.

Jerry Overman: Okay.

(Chris Norton): How to anticipate problem medication discontinuation, you know, yes.

Jerry Overman: Yeah. I really don't know of any good guidance other than, quite honestly, clinical experience. I get these questions all the time.

I actually, I've worked in various institutions in various settings, one of which was a place where we were getting patients ready for protocol or getting them ready for research so we had to do it. And it's pretty amazing out there what, that there really is, appears to be a lack of direct help.

What I do and when I work with my and have worked with my teams over my career, whether it be at a state hospital or a VA or whichever, is I look at half life first. I look and to see specifically with how long it's going to take the drug to come out of the system.

Some of the things I know I just happen to know by direct clinical experience. There are certain antidepressants— most antidepressants—you're not going to stop cold turkey. You're going to do it nice and slow. There are a couple that actually, you probably can stop cold turkey, like Prozac, just because it has such a long half life.

Bupropion is an antidepressant that we do feel pretty confident not worrying, having to give the big, long tapers because I'm sure you've had patients who have come off of SSRIs—or selective serotonin reuptake inhibitors—and it can be a very, very problematic thing.

So for those big, major issues, there will be literature in things like the SSRI withdrawal phenomenon. And you can look through the literature that way. But as far as clearinghouse or help, just because—as the number of medications has increased over the years and multiple medications being used together, you know, we tend to look at each drug, see what class they're in, see their half life, and process through it that way.

Wish I could have, I wish that there was some information out there, but it really does appear to me through my experience, since I graduated in '94, that even once you know that information, it really does appear that every patient—in a certain, in certain ways, is different. And so you might have to just kind of do it trial and error. I don't know if you had anything to add, Karen.

Karen Weiss: Well, I was just going to sort of reiterate and sort of empathize or sympathize with the person that had the question as well as what you said, Jerry. It's a very difficult area. And I think it's particularly problematic in the area of mental health and the multiple medications that individuals are on, but it isn't necessarily unique, even though that's probably small comfort.

There's —polypharmacy is a huge problem, particularly in the older population who have multiple chronic conditions, are on all multiple medications, and some of them are the same individuals with some of the mental illness.

And it seems to me it's, in practice that what happens is that oftentimes medications are added and the old ones aren't necessarily taken away. And so you get this compounding problem.

And you mentioned, Jerry, in your talk—and it's a really important issue—that whole issue of medication reconciliation and MTM or medication therapy management, which is actually becoming more and more an important quality measure of, you know, how our organization's actually showing that they give quality care. And MTM is one of those things.

And what, I know it's very resource intensive, but when you have teams with individuals like the pharmacy community such as, you know, such as you, Jerry, as part of a team in various health care settings that carefully try to coordinate not, you know, a pharmacist, the health care providers, the health educator, et cetera, a whole team approach where they actually try to really carefully evaluate one's medication records and have, one, an accurate portrayal of what everybody's on and then assess whether or not they're needed.

Unfortunately, there aren't good clinical data. I mean, there aren't, you know, I think what's really needed are good trials to try to assess what is the impact of decreasing or taking off medications.

And because there are so many variables in there, it's very, very hard, I think, to try do these kinds of trials. Hopefully, with various types of biomarkers and other ways to try to evaluate some of the individual patients, you know, things would be better I think in the future, but it's a huge problem.

And as we get more medications and there's more of an urge to put people on medications, I think there needs to be really careful thought to managing and coordinating individual's care. It's an excellent question and I don't think there's easy answers.

Coordinator: Thank you.

Mark Davis: This is Mark. I'd like to add that this is an excellent example of a partnership of not going to our isolated silos to discuss this but coming together. As the, you know, those of us that know our bodies and are or aren't taking the medications and that, you know, if we all look at this separately, we're going to have pieces of the answer and not the whole thing.

I'd like to give an example of—there's a genotype test that will determine, a blood test that will determine which HIV medications are working or not, simply put. And my combination with working. My viral load was undetectable and my T cells were high, which is good, but it was causing side effects that—cholesterol, kidney, you know, all these other side effects.

So, I basically, with an undetectable viral load, had to stop the medication with my doctor and grow the virus back. And then, in six weeks, once they had a virus to test—they did the genotype test that could indicate which medications I would go on next. And the acronym now is they begin with S-P-I-N, so I'm taking it out for a spin.

Unfortunately, I became one of a percentage of people that got violently ill for 5 weeks, and so, but I guess the good news, I can say out of this, it's the first time I've been under 200 pounds this whole millennium, so, you know, that's just one thing.

But the point is, is that we need to work together and collaboratively in order to find the solutions.

Leslie Brenowitz: Thank you, everyone. And Mark, that actually leads in very well to one of the questions we've gotten online from someone in an agency trying to reduce unnecessary polypharmacy. And she says many people have been well-trained to be compliant and are afraid to discontinue medications that may case metabolic syndrome and other side effects.

From the perspective of a consumer, how would you address the issue of people's fears and their choice in terms of the medication discussion? And I'll just remind everyone if we could keep our—I know these are complex issues—if we could keep our questions and answers as brief as possible.

Mark Davis: Right.

Leslie Brenowitz: ...so that we're able to get to as many folks as possible.

Coordinator: Are you ready for one on the line?

Leslie Brenowitz: No.

Mark Davis: So the question was basically how to—I think it's an individual approach, and I think it's, you know, it's the needle in the haystack perspective.

What's worked for me are combinations at low dose. And it's a matter of discovery and—but the ultimate goal is, you know, reducing the side effects, you know, getting rid of the depression, you know, and just stabilizing all of those factors and, you know, the narcolepsy and everything else that comes along with it.

So, you know, I feel like a mini-pharmaceutical, but I feel like I've come to a balance. And it's all about choice and really, you know, finding an individual answer.

Leslie Brenowitz: Thank you, Mark. Let's go to another question on the phone.

Coordinator: (Lois) your line is open. Go ahead, (Lois). Your line is open.

(Lois): Yes, this is (Lois) from the VA in Menlo Park. Wondering about, when you start on these medications, is there a time limit for the metabolical changes so that after six months things level off and you know what to deal with, or is this going to be a constant plus or minus thing going on?

Jerry Overman: This is Jerry. The weight gain can happen just about at any time, but we tend to—so we tend to monitor it chronically. So the—and the other issues related to the weight gain and the cardiovascular health issues are things that really need to be in the forefront of your mind through the whole process. Not just in the beginning, not just after six months, but over the long haul.

I do, just from my own clinical practice, I have seen patients who don't develop weight gain or that develop minimal weight gain. And in fact, some patients start on clozapine and lose weight, so there are those people who don't tend to have what you would—the side effects you would expect them to have.

But when it comes to weight gain and the eventual other issues, it can happen at any time. And also release that the medications are a big part of it, but also other lifestyle changes could be a big concern. So monitoring, you know, for the long haul is generally good.

And working with a relatively young schizophrenic population that I work with at the present time, it's, it can be real frustrating for them to hear, as they're just recently diagnosed in their late teens or early 20s, that this is something they're going to have to keep tabs on.

One thing I didn't mention—and I don't want to belabor the point—but even keeping the diet the same way that it is and exercising isn't even enough, in some instances, to keep weight off. So, you know, so patients almost have to do the, go the extra mile just because there is some data out there that shows that even when you are, patients are doing the things that they need to do, that they can still continue to gain a little bit of weight.

Karen Weiss: Could I ask, Jerry, as sort of follow up—this is Karen Weiss. Is that...

Jerry Overman: Yes.

Karen Weiss: ...am I allowed to ask a quick question follow up?

Leslie Brenowitz: Of course.

Karen Weiss: Okay. So, Jerry, I was just curious to know, as I'm, -personal interest in this particular question, but with the metabolic changes, weight gain, et cetera, when somebody goes off their medication, do things reverse? Do we have enough longer-term data to know what happens?

Jerry Overman: No, I don't know of any truly long studies that looked just at that question, but clinically the answer is yes, at least partly. When we have patients in various research institutions that I have worked over years where we might take a patient off of a medication or in a hospital where I'm working clinically where we take a patient off of one of these, especially like a medication that's really a big problem like olanzapine or clozapine, you can definitely see weight loss.

I've actually, you know, the thing is that, you know, you want to also make sure to weigh that with the behavioral changes that occur.

Karen Weiss: Do the metabolic—other parts of the metabolic syndrome also tend to get back to normalcy as well?

Jerry Overman: From what I've seen in most cases, yes. Or there's at least improvement. You know, you also have to consider that if this is a long-term treatment, our bodies change as well. So you, you know, if you're on an atypical antipsychotic for a long period of time and you're ten years older than you were when you started it, you're not, you know, your body overall...

Karen Weiss: Right.

Jerry Overman: ...changes...

Karen Weiss: Right.

Jerry Overman: ...as we age as well.

But for the most part, I have seen a number of patients gain a lot of weight with lithium. And we didn't talk about lithium today. Issues with—people get acne with lithium, we can kind of see the weight-induced lithium—weight gain that's induced by lithium and acne as well. Those things kind of clear up.

So side effects, in general, we tend to see, for the most part go away. One major difference there is Tardive Dyskinesia, but that's another reason why we got away from those older, typical antipsychotics.

Mark Davis: Let me also add that from a person using perspective, the use of a mood chart. It's hard for me to remember yesterday let alone the next time I see my psychiatrist what's going on. And it's a simple one-page—the whole month.

It basically—you keep track of your daily moods, and I'm sure you could probably find a copy of this online somewhere, but it's a very simple way of just getting them into the habit of writing little notes about, you know, what's going on each day related to your medications and your mood and your environment and so forth.

Karen Weiss: I think that's an excellent idea, Mark, and one that probably prescribers should really ensure to try to make—to try to ensure that their patients actually use those.

Leslie Brenowitz: Thank you. Let's go to the next question.

Coordinator: Okay, I have (Maxine), your line is open. (Maxine), go ahead.

(Maxine): Hello. I have a question regarding medication-resistant diagnosis, which my family member has, and I think the worst effects are the metabolic syndrome. I wanted to know your views on two things. One is complementary treatments not requiring medication such as yoga, acupuncture, dancing, use of dietary supplements.

And then secondly, the use of brain - electronic brain stimulation. I can't remember the name of it. It's not (ECC) but it's another type of brain stimulation, which I understand has been approved by FDA but not widely used yet.

Leslie Brenowitz: Let me say on the complementary and alternative treatment topic that we don't really, you know, have anyone who is an expert in that area on the call today. I would refer you to the National Center for Complimentary and Alternative Medicine at the National Institutes of Health.

(Maxine): Thank you.

Leslie Brenowitz: ...and their Web site is nccam.nih.gov.

I will say that we are hoping to put together a future training teleconference on prevention and holistic approaches to wellness. So it, you know, we know it's certainly a topic of interest.

On the other part of your question I, you know, Dr. Weiss of course doesn't represent the approval process at FDA, so I don't know if you have anything to say about that.

Karen Weiss: I just know—well, EBS, or electronic brain stimulation, is an approved therapy. It's not a drug. I mean, I'm in the Center for Drugs. This is actually regulated in the Center for Devices and Radiologic Health. And I know it's an approved therapy for a number of different disorders. I think primarily more in the Parkinsonian and some of the movement arenas.

And so, that's probably about the extent of my knowledge about those therapies, but they are available. And there's information that one can actually get from the FDA. There are consumer-related Web sites and even individuals that actually are available to talk to consumers that call in try to—who want to get additional information about these therapies.

So I just want to quickly mention the things that—and I agree totally with referring to the NIH and the Complementary and Alternative Medicine. One thing that's important to recall when we were talking a little bit about polypharmacy and interactions, it's very, very important for patients and their providers to have conversations to really get a full picture of everything that the patient is taking, because sometimes individuals are on other complementary alternative type medications or herbal therapies or whatever that they may not consider to be a medication, but it might have important interactions with other medications.

And so it's just very important that everybody remembers to specifically solicit information and provide that kind of information.

Mark Davis: I'd like to thank the caller for this question because I'll simply say it fits into my mess. Alternative—it's not just about medication and, you know, it's a part of a holistic approach that I choose to use, you know, to clean up my mess and to live a happy life.

Leslie Brenowitz: And I should also add that while the focus of our call today is, you know, primarily on medication and Safe Use, that the perspective of many, including the 10x10 Wellness Campaign is that wellness is defined by a range of aspects in a person's life. And that's certainly beyond physical health. There are spiritual and emotional and other, you know, components that make up wellness for a person.

We do have a question online. Actually, a couple of questions —and, Karen, I don't know if you're able to respond to this or not—related to Safe Use in prison and if anything is being done on monitoring the effects of medication used for mental health problems in prison and then, you know, any, I guess, maybe partnerships or work with other agencies, particularly around safe use, for people who are in prison.

Karen Weiss: I think that's an excellent idea. I don't have any specific involvement or have —it's actually something that hasn't come up and we've had a lot of outreach with many out there in health care to ask what individuals or groups, organizations think are some of the big health-related issues that might benefit from our Safe Use Initiative.

And so we've gotten lots of input because this initiative won't work unless it involves those who are really the providers or the consumers of these medications.

So that—we clearly are interested in vulnerable populations. I started out my work in the pediatric realm, which is a very, I consider, vulnerable population, but I think individuals in prison is one that doesn't always rise to the forefront. So I'm going to like add it on to my list.

And I would just ask whoever's put that in, you know, if you ever have an opportunity to actually get back with me maybe offline, I'd love to hear a little bit more about what potential opportunities are.

We've talked about things like, you know, in the young adults reaching to specific populations like college campuses and health centers that are on college campuses and ways to try to reach specific groups.

This poses, in some ways, new challenges, but other ways, it's sort of—in a way—more, maybe an easier opportunity to reach certain populations that are, you know, that are in, comfined, and so they're less out there in the community and there's maybe more oversight and maybe more ability to develop interventions and partnerships.

So I would love to continue some of that dialogue. And if you have the opportunity to actually get back in touch with me since my e-mail is on that Web site, that would just be really something I'd be very interested in doing.

Mark Davis: I'd like to put a plug in for certified peer specialist in any environment, whether it's a forensic hospital or a psychiatric hospital or in a community mental health center.

Peer support is invaluable to develop safe environments for people in any location to come together in a safe place to learn from each other and to benefit from each others' expertise, because certainly I would assume, you know, like, you know, sometimes in community mental health it might be a 15-minute visit with a psychiatrist.

And so people struggle with having, you know, the time to work with and be listened to. So peer support is a supplement to enhance in any environment, including in forensic or prison environment.

Leslie Brenowitz: Thank you. Thank you very much. Can we go to another telephone question?

Coordinator: Actually, at this time I show no questions.

Leslie Brenowitz: Okay. So if you do have a question, please dial star 1 on your phone or click on the Q&A tab at the top of your computer screen. And we'll just wait a moment in case there are other questions.

I'll say while we're waiting that this call will be archived, the PowerPoint presentation as well as the PDF version. A recording of the teleconference and a written transcript will all be archived on the SAMHSA 10x10 Campaign Web site in the training section, and we have the previous calls that we've done, including one we did a couple of months ago on tobacco cessation archived there.

And for those of you who participated on the net portion of the call, we will be sending you tomorrow a very brief survey. Your response is anonymous. It takes about 5 minutes to complete. You do it right online and it's very useful to us in continuing to hone both how we conduct these trainings and the kinds of topics that we would—might cover in the future.

Additionally, we welcome you to contact us at 10x10—that's 10-x-10—at SAMHSA.hhs.gov. Operator, do we have any...

Coordinator: Yes, we do.

Leslie Brenowitz: Okay, great. Go ahead.

Coordinator: (Tamela Wilcox), your line is open now, ma'am. Go ahead.

(Tamela Wilcox): Thank you. My name is (Tamela Wilcox). I am a contract consultant with the Wellness Management and Recovery Coordinating Center of Excellence in Ohio. And basically, we have created a curriculum for people with mental illness, and I'm wondering how the rest of the country feels about a curriculum that is facilitated by both a professional and a peer and how that would work within the system, if that makes sense.

Karen Weiss: Are you asking specifically about curriculum that might be around the development of a treatment plan...

(Tamela Wilcox): Yes, ma'am.

Karen Weiss: ...and medications? Okay. Mark, it sounds like...

Mark Davis: With—is there—yes, this is Mark. I'd like to say, “Go, Bucks.” I'm a Buckeye forever, although I've been here since '84. And any place we can have partnerships and dialogues and work together on curriculums and teach together and learn together is greatly encouraged. So, you know, I support that 100 percent.

And sometimes it feels like we're recreating the wheel and there's great expertise out there. It's a matter of finding it. The web and the internet phenomenon has certainly helped us find it. Sometimes it becomes overwhelming to keep looking for it.

And I'd also like to encourage that consumers be involved on any FDA panels. As, you know, it's not about us without us, and we need to be everywhere because we're just as much an expert as a person living with as a person with a Ph.D. In fact, my initials are M.A.D., so I, you know, that's my degree.

Leslie Brenowitz: I would also point to work done by SAMHSA and others on shared decision making. And on SAMHSA's Web site in the consumer/survivor area of the Web site there are links to a number of materials related to shared decision making.

And I think, you know, Mark's comments assert that it is very important for people to be involved in decisions about their own treatment and to be empowered to do so.

Do we have any other questions?

Coordinator: I have one more standing by. (Karen), your line's open. Go ahead.

(Karen): Hi, I'm (Karen). I'm a certified recovery peer specialist and a disabled veteran in Pensacola, Florida. I want to play devil's advocate for a minute. Somebody mentioned working in a VA earlier. When I see my psychiatrist at the VA, I have no choice. I have no options. I take what they give me.

The pie in the, it's like a pie in the sky here now what you all are talking about and sometimes the reality of the situation. If they don't have a generic in the pharmacy that they can dispense, well I'm out of luck. I go buy me a civilian psychiatrist and pay out of pocket? No, I don't think so. Not on my income.

So any thoughts to, I don't know, to getting around some of these obstacles or to living with some of these decisions that I know could be better? I have a hard time sometimes living with, I'm on this medication and I hear people talking about that medication. But I can't have that medication. Thank you.

Coordinator: And that was the last question I had online, ma'am.

Leslie Brenowitz: Okay. Mark, do you have any thoughts?

Mark Davis: Well, I've just—are you a certified peer specialist in the VA system or in the community system?

Leslie Brenowitz: I think she's now just in the listen...

Mark Davis: Oh, okay.

Leslie Brenowitz: ...but I think she said...

Mark Davis: I would encourage...

Leslie Brenowitz: ...that she was a certified peer specialist in the VA system.

Mark Davis: Yes. And, you know, the—it happened there. And to infuse the education, this really needs to, you know, the veterans that you—there are so many people at risk for suicide and I know many people in the system that express the same things, that this really needs to be looked at.

I would encourage the person to find the peers wherever you can, and to advocate from within as much as you can. And that's easier said than done.

Leslie Brenowitz: Yeah, thank you, Mark. And so with no further questions, I want to thank our speakers, Jerry Overman, Karen Weiss, and Mark Davis so very much for your time and this very useful information you've shared.

If you were participating on the call today and found it useful and want to recommend it to others, do know that it will be archived and made available. And please do reply to our brief survey tomorrow so that we can continue to provide trainings that are useful. Thank you very much.