Travis County Commissioners Court
Tuesday, June 29, 2010,
Item 11
11. Consider and take appropriate action regarding a resolution endorsing the university medical center at brackenridge's protect and erythropoietin research and experimental clinical treatments for traumatic brain injury as part of the community consultation and public disclosure processes for this study.
>> good morning.
>> good morning, judge. Good morning, commissioners, my name is ashton, vice-president and -- for the seton family of hospitals, i appreciate you having us here this morning. Before i get started, before we get into the meat of the matter, let me introduce some of the folks that are with me. To my right i have dr. T.j. Milling the principal investigator. To my left assisting with audiovisual is ben king the project manager for the hospital and clinical research. Then as part of our community support, we have individual with us this morning, chip howe, who is the admissions coordinator for the mary lee foundation, which as you know is a residential and educational service provider for individuals recuperating from brain injury. Mr. Howe was also part or not just part but one of the commissioners on the austin mayor's task force for people with disabilities, although he is here in his individual capacity. We're here this morning, judge, to -- to as you alluded to, to talk about a study that's looking into efficacy of two medications, progesterone and what i call epo, i'm going to say it's erythropoietin
>> that's good, it's erythropoietin
>> okay. Erythropoietin , okay. Two hormones normally found in our body, but to see whether or not they have the ability to help reduce swelling for brain injuries and -- and other traumatic brain -- brain concerns. You might recall that we were here in 2008. On a similar process. When i say similar process, this is part of our community consultation and public disclosure process because for brain injuries, as we were here for epilepsy in 2008, individuals suffering from those generally are not in the position to give consent at the time that they need medical treatment. I'll just mention briefly and dr. Milling will say more about it, the 2008 study, that you helped us with again, regarding epilepsy, which was a national institute of health study, is still ongoing. It's going very well. And nih is very pleased with our progress. The doctor will give you a more detailed update in a second. This particular study, as i mentioned, deals with progesterone and epo, i'm going to tell you that the progesterone part of the study is the study of the national institute for neurological disorders and stroke as well as the neurological emergency treatment trials network or net for short. Which is funded by nih. Also mentioned that the net network conducts studies to learn how to to improve emergency care for severe injuries and illnesses for the brain, spinal cord and nervous system and the net network is made up of 17 hospitals throughout the nation. The university medical center at brackenridge, which of course as you know is a level 1 trauma center is the hospital that is participating in the austin area in this study. As far as epo, it's also funded by the national institute of neurological disorders and stroke of the national institute of health and it is also taking place atmosphere the university medical center at -- at the university medical center at brackenridge. At this time i will turn this over to dr. Milling. One individual who will be participating with us, but participating via electronic media, that's dr.
>> [indiscernible] dr. Milling?
>> thank you, ashton.
>> i'm sorry, one last thing. I also would like to thank sherri flemming for her assistance in -- in helping working with us on this project.
>> it's been a group effort. Judge, commissioners, great to be with you this morning. I spoke with some of you last -- last year, the year before regarding the ram part study which is the seizure study that ashton just mentioned. It's been very successful here in austin and elsewhere in the country. Ahead of schedule. Made nih very happy from a funding standpoint, gets us that much closer to anxious the question of which of these two medications are better for patients who are seizing in the field. So thank you for your support of that study and we help to bring that to a close in the next couple of months. As we told you then, there were other studies in line behind this one from the neurologic emergency treatment trials. Nih collaborative from some pretty big named hospitals and austin has taken its place in that network of leaders in emergencies which include seizures, these other two studies, which are regarding traumatic brain injury. As ashton said, patients who are seizing or for that matter having a stroke or having a major traumatic brain injury, can't consent at the time of the injury, but by definition they are either unconscious or altered. We need to know which therapies work in traumatic brain injury so that we can actually help them. We really haven't found good therapies for -- for treating traumatic brain injury. We can determine if there are clots inside their skull, we can remove those clots and decompress the brain. But as far as saving the brain itself, we haven't found the perfect therapy for that. Then these two theamps have been in -- therapies have been in -- in many phase 1 and phase 2 early trials, animal trials. And then followed by smaller human trials and they are now at the very sort of end of this process, phase 3. With some major funding from the nih because there are -- they are our best hope for improving the outcomes in traumatized patients. So -- so if you follow the normal consent process, it's about a 13, 14 page document, you go through it with the apparent, you make sure -- with the patient, you make sure that they understand everything, they decide whether or not they want to be in the study, they get randomized for either the drug or placebo. Obviously you can't do that in a patient who has been a car wreck, unconscious with a major traumatic brain injury. As in the seizure study, the f.d.a. Created another pathway for -- for essentially exception for informed consents and it requires us to reach out to the community in which the research is to take place, consult with the community, get their feedback and disclose publicly about the study and then the default setting becomes to enroll them in the study. It's not like we're trying to thwart that very important consent process. There's no other way around doing this kind of research. We can't throw up our hands and say we can't research it. That would be surrendering to the disease and saying we can't improve outcomes. What we do is try very hard for about an hour to find someone who can consent for the patient, a spouse, a family member, somebody legally authorized representative status and try to consent from them. If we can't find that person, we enroll them in the study and they get randomized either to the placebo or the drug, in this case progesterone or erythropoietin at some point after that infusion starts, a patient's representative shows up or the patient themselves wakes up and says i don't want to be in the study we stop everything immediately. But this is the only way to carry out this kind of research. And this is coming to you again as we did last year as parts of that process. --
>> doctor, can you explain to -- to us and to the viewers how treatment, if at all, is different for someone who is in the study versus someone who is not. This is an excellent question. Many studies have been done just comparing patients in studies versus not in studies. Patients in studies do better overall. Whether or not they got the active drug or the placebo. Just because things are so protocolized and carefully monitored and watched within a study, so research is good for patients. Within the study, everybody gets this standard of care. We -- we just came from a meeting in atlanta not a month ago where experts across the country sat down and agreed to what was the -- the best approach for all of the other things that happened in traumatic brain injury besides the investigational drug in this case which is progesterone, a hormone, in your body already just given at a slightly higher level. That happens regardless of which group you are randomizing to. The one thing that is different, either get the progesterone or don't.
>>
>> [one moment please for change in captioners]
>>
>> how determine who will be in the stawnd who will not?
>> there is some criteria for the protect study it's moderate and severe brain injury. It's the coma scale, gcs, it's based on how the patient is acting when they come in, whether their eyes are open, whether they're following your demand command.
>> did you make that 100% of the patients that meet that standard are in the study?
>> right. If their mental status as defined by the dcs is depressed below -- 12 is the number, but -- which is a moderate injury, meaning this is a patient who is not able to answer your questions usually. They could are random eyes understand the study. There are also some other excludes criteria, we don't usually want to give hormones to a person who might have a hormone cancer. If we know that about them or we see stars consistent with mastectomies, we wouldn't enroll them. Hormones have different -- kids, hormones have different affects in developing bodies, we don't know how old they are, but we can make a determination. There's a scaling system that is fairly accurate for us to not enroll children in a hormone study.
>> these are the most traumatized patients. These are very sick patients who have extremely poor outcomes usually and that score is much lower for them.
>> so is this community consent being upheld by courts nationwide?
>> it was part of the f.d.a. Recognizing back in 1986 when -- and ben could tell you the rule numbers. Cfr --
>>
>> [inaudible - no mic].
>> there you go. So they recognized that we were not making any progress in research on emergency conditions because of the way the process was not set up for emergency research and informed consent process and while it all very important and we understand and we certainly are not trying to preempt it or go around it in any way because it is important for the consent of the person in the research being done, but to balance that against the type of illnesses we're taking care of. As far as have the courts supported it, it hasn't been challenged to my knowledge since the f.d.a. Passed the rule in 1996. It is routinely carried out at most major medical institutions. The other institutions taking part in this study include penn, ucff, yale, and you can probably --
>>
>> [inaudible - no mic].
>> baylor in houston, down the road.
>> in the prior seizure study, i recall there were two different medications and there was very little evidence-based research to indicate which was better under certain circumstances. In this instance is the issue with the -- these two medications, these are separate trials for these two medications, is my understanding. And am i understanding that at this point there isn't adequate research to indicate whether not giving it or giving it is best under these moderate or severe circumstances?
>> doesn't of this trial is a little different. In the seizure trial we had two medicines commonly used to treat seizure, and we were in a position where both -- they were both proven superior to other therapies, but had never been sort of compared head to head. And one had the advantage that it could be given in a muscle as opposed to being given into a vein, which is really hard to get an iv in a patient who is actively seizing. So that would be a benefit to patients and to the emsz crews who take care of them. In this situation we have a drug that is a single drug that -- or two drugs separately that have gone through the f.d.a. Phase 1 and 2 process, the first of course we're experimenting in animals and in a smaller human trial, and have shown benefit in those trials. The stage 3 trial is the larger trial, in this case a thousand patients to prove that it does indeed improve outcome or there are stopping rules -- if it were to make it worse, they would stop the trial at a certain point. Or if it showed no difference we stop the trial. Or if it shows some great benefit over the first couple hundred patients, then we stop the trial and declare that it works as well.
>> okay.
>> so the results of our study are combined with results of other studies in other parts of the country and at some point, i guess, experts get together and --
>> write the paper. So we will probably -- we're estimating we'll enroll about (indiscernible) patients out of the total 1,000. It's blinded, so we don't unblind it until we have all the data from all the sites and then we all get together and examine the data and write a manuscript and submit the results to the f.d.a. That said, there is something called a data safety monitoring board, dsmb. They monitor the data all along and they're looking for trends, as we talked about, stopping rules, evidence that we don't need to continue the study because it's already proven it works versus it's not really making enough difference for us to continue this versus it may actually be harmful, so we stop immediately.
>> in the combined studies that's taking place i guess all over the nation, when would you anticipate it would go before the f.d.a. And --
>> given the size of the study, the number of the hospitals involved, we were expecting it to go on for three years.
>> three years?
>> yeah.
>> okay.
>> and although this is community consent for travis county residents, it would only be traumatic brain injury emergencies that are going to brackenridge.
>> right. Because -- it's community consultation. There was an old federal rule that called it community consent, but that term sort of fell out of favor when the new cfr came in. And i saw ben looking at the -- we need to clarify that. But brackenridge is the trauma center in austin, so all of these moderate to severe brain injuries go there and that's where they're cared for. That isn't to say that other hospitals in austin won't be taking part in neurologic emergency treatment trial studies and we have some others that will be going in seton and other hospitals in austin. But when it comes to trauma, yeah, brackenridge and pediatrics eventually will bring dell into that if we do those type of studies.
>> any other questions or comments? Move that we approve the --
>> i'm sorry, i forgot about the video. It's brief. Talking about the study.
>> my name is (indiscernible). I'm a neurosurgeon at the seton brain and spine institute. I'm sorry i can't be there in person, but i'm giving presentations and learning from my colleagues. I've been in austin for about seven and a half months and before that i was on the faculty of the medical schools in houston, mostly baylor and some at the university of texas in houston. My major area of interest and research is neuro trauma and critical care, especially traumatic brain injury. And while in houston i was lucky enough to be the lead investigator on a very large department of defense grant that involved dozens of investigators and was awarded over $33 million to the local economy there. So i've seen firsthand not only the personal tragedy associated with neuro trauma, but also the positive financial impact that research in this area can have on the community. Now, to put this in perspective, brain injury is something that occurs 1.5 million or perhaps two million times a year in this country resulting in approximately 230,000 hospitalizations and 50,000 deaths. Put that in perspective, that's -- that compares to about 175, 180,000 new cases of breast cancer diagnosed every year. So that number is less than the number of people admitted for brain injury. The number of new cases of hiv and aids is about 45,000 per year, less than the number of people killed by this disease. So for whatever reason you don't hear as much about brain injury, that's why it's been called the silent epidemic. And clearly new treatments are desperately needed. Dozens of trials have been done in last few decades and a lot of money invest understand this. And although we haven't come up with a cure or a treatment yet, we have learned a lot from these trials. The one thing we have learned is that any treatment we give has to be given very soon after injury. It is not the thing that can wait after 9:00 on monday morning. Of course by the nature of the disease, many of these patients are not awake and alert and cannot consent for themselves. So what do you do at 2:00 in the morning with a patient who may be eligible for an investigational treatment that needs to be given within a few hours. But the patient can't consent for himself or herself and no family is available. That's why the federal government has created this process for exception from informed consent. Now, dr. Milling is talking to you about the protect study and i'll be talking to you about a study for something called depo, which eats for erythropoietin, which is a naturally occurring compound that your body makes to produce red blood cells, which are the cells that carry oxygen. It's a very controversial debate right now about how much you need to transfuse these patients to keep the blood cell massty critical level. This drug seems to be very safe in preliminary studies. If you've transfused at very high levels or give so much of the drug, you want to maintain the high museum mow globin, you may have thrombosis or blood clotting, but at the levels we're targeting in the study that should not happen. Rarely it can cause elevated blood pressure, but that may actually benefit these patients and anybody with severe preexisting disease won't be enrolled. Again, the key factor here is the patients need to receive this drug very early after injury. There's a powerpoint presentation from our colleague claudia robertson at baylor, who is a lead investigator, which spells out mostly the safety and the laboratory and preliminary studies. The drug has shown some promise in smaller pilot trials and in some other conditions, but no one has ever looked at it to try to help cure this devastating problem, which is devastating not only financially, but also in terms of the tremendous human cost. Thank you for your attention.
>> that's it, commissioners, judge.
>> thank you for your time.
>> thank y'all. Ben does have some surveys that he can hand out as part of the process.
>> you guys have the surveys. Part of why we're here is to collect feedback both from the attendees and from you guys as far as your thoughts and feedback and so if you could take some time, we'll be here to collect those later today.
>> move that we approve the resolution.
>> second.
>> discussion? All in favor? That passes by unanimous vote. Thank y'all very much.
The Closed Caption log for this Commissioners Court agenda item is provided by Travis County Internet Services. Since this file is derived from the Closed Captions created during live cablecasts, there are occasional spelling and grammatical errors. This Closed Caption log is not an official record the Commissioners Court Meeting and cannot be relied on for official purposes. For official records please contact the County Clerk at (512) 854-4722.
Last Modified:
Tuesday, June 29, 2010 2:35 PM
