Estudo de Caso 03 Avaliação de projetos internacionais à luz da regulamentação brasileira para a pesquisa envolvendo seres humanos Um estudo multicêntrico, internacional, aleatório, para comparar o desempenho de dois modelos de implantes contraceptivos para mulheres foi submetido a um comitê de ética no Brasil. O estudo será realizado simultaneamente em 10 países em dese
Microsoft word - 44d7940a-4ed9-282a42.docAbout Health TV with Jeanne Blake
Hi, I’m Jeanne Blake. Welcome to About Health. We have an important topic and a very special guest for this edition of About Health. The topic is the most common cancer in men over the age of 50. The cancer is prostate cancer, and our guest is a man you will recognize, who’s using his personal experience to help educate you about this disease. And he’s one of the classiest men that I’ve been privileged to know, WBZ-TV’s Charlie Austin. Welcome, Charlie. CHARLIE AUSTIN: I’m feeling pretty good today. I say that a lot, because some days, depending on how the medication is working in my system, I have a good day and a bad day. But today is a good We’re glad to hear that. Let’s start with a little bit of a biology lesson before we get into some of the details of what this has been like for you to live with this. The prostate: tell us what CHARLIE AUSTIN: It’s a walnut-size gland that is used to produce the liquid that goes through the semen, through your urethra. It’s behind the bladder, and it’s there and it’s useful when you’re a young man, and as you get older it becomes less useful. And almost every man we know will know that someday that prostate will be enlarged or maybe have cancer. But most men don’t know where it is. You said one out of ten doesn’t know. Why do you think that is? One out of ten CHARLIE AUSTIN: In talking to my urologist, Dr. Frank McGovern, and he said, Do you know that we did a study in the urology department here at MGH and other places, and they found out that most men, when you ask them Where’s your prostate? they don’t know. One in every ten men do know. Why are we so ignorant about that? Is it a part of our anatomy that we don’t want to talk about, or part of the sexual thing that we’re afraid of exploring? Or we just want to wipe it out. I knew where it was when I went in the Army, because there was a prostate rectal exam. That was the only time I remembered. But after that, I just forgot about it. I wasn’t informed about it, and I should have been. Until a year ago, then you found out where it was. CHARLIE AUSTIN: I was reminded where it was and what it’s supposed to do. CHARLIE AUSTIN: Wel , the first symptoms were getting up in the middle of the night, two or three times, to go to the bathroom. And then feeling like I was never completely empty, never completed voided. And I had to go back again, and never completely finishing, like I always had the urge. How long did you experience that before you said, Wait a minute, something’s CHARLIE AUSTIN: About a month and a half to two months. CHARLIE AUSTIN: Wel , see, I had a stroke and an aneurysm about 11 months before, and when you’re recovering from trauma to your head, your body is doing all kinds of funny things. So I’m passing this off as maybe a residual from the stroke or from the aneurysm. I’m just saying maybe I’m drinking too much after 10:00, no more coffee, no more Coke, no more caffeine. I’m just doing things that I think is going to help. Then I spoke to my brother, who had his bladder removed because of cancer, and I came back and I found a urologist, and I was diagnosed with advanced prostate cancer. When you say advanced, what does that mean? CHARLIE AUSTIN: You can have prostate cancer at different stages. Advanced prostate cancer means it’s probably, in all cases it’s left your prostate, it’s gone outside, it’s in your lymph nodes, or it could be in your bones or any other part of your body. Once it goes outside the prostate, it’s advanced. OK, let’s talk about the personal side of this for just a minute. What was that like? Cancer is probably the most dreaded word for all of us. What was that like? I’m sure you remember the very moment that you were told that you had cancer. CHARLIE AUSTIN: My wife and I were suspecting the worst when I was first diagnosed, but we didn’t know exactly until the blood test came back, the PSA test. I want to go into that in just a minute, because that’s really important information. CHARLIE AUSTIN: Once those numbers came back that told us what my rate was, how high my number was, I knew it was very serious. I knew it was not – the lower number means I could probably have the prostate removed and get on with the rest of my life. CHARLIE AUSTIN: If it had been a lower number. But the higher number means very serious, very aggressive cancer, time to take some hormonal therapy and radiation and go after it aggressively. If But what was it like the day that you were told? Do you remember, did you think, I’m going to die? You were always so optimistic. You’ve got a wonderful zest for life. I’m just wondering CHARLIE AUSTIN: It felt like the end of the world. It felt like I was going to be leaving in a month or two. Because when you hear cancer, advanced prostate cancer, anything that has advanced beyond, it’s like, OK, I know what this is, I’m depressed, I’m angry because I didn’t know more about it. But I have a wife, Linda, who’s there, and she’s just like a rock. She’s my mustard seed. She said, OK, we have to learn more. Let’s understand it. Let’s study the enemy and know how to beat it. So I went from fear, anxiety, and frustration to anger to get this thing beaten. One to the other, very quickly. What do you think the role of – and actually it could have gone either way – of your having had a stroke? You, I’m sure, had to deal with some, Wait a minute, why is this happening to me with a stroke? And I’m sure that you were like, Wait a minute, this is impossible that I would be CHARLIE AUSTIN: I said, You’ve gotta be kidding. I was only, at that time I was 51 years old. Prostate cancer? That’s for my grandfather, or somebody beyond me. I’m too young. That’s what I kept saying, I’m too young. But I found out African-American men who get it at my level, their survival rate is very, very low, because your hormones are there, your testosterone level is very high, and those are the two things that prostate cancer likes to feed on and spread very rapidly. Charlie, before we get too far away, because I know that you’re really wanting to educate other people about this, and I think it might be helpful for us to put the symptoms up on the screen and have you go over them with us and tel us which ones you’ve experienced. Although these symptoms, I believe that, correct me Charlie, you’re the expert, if you have any two of these symptoms CHARLIE AUSTIN: Any two of those symptoms combined, you could have a case of enlarged prostate alone or the beginnings of prostate cancer. I had the first one, frequent urination, difficulty starting, weak, interrupted urination stream. And my bladder never felt empty. There was no blood in the urine, no pain, no problem with sexual intercourse, no stiffness in the back. But I did have, I do remember now, I did have a pain in my lower back. So the pain in the lower back, the urinating problems, all of those things were part of what was going on. I’m thinking, that’s just another problem How much of it do you think was classic denial, which we all have at some level? Or it was, as you said, the fact that you were trying to figure out, get back to the old Charlie after your CHARLIE AUSTIN: I don’t recognize that I had a denial issue at that time. I really think I was trying to figure out what was wrong, but I was under-educated about my prostate. I didn’t know what I know now, today, about where it is, what it is, how it functions, and what the symptoms are. And the value of PSA, which is – help me again, what is that an acronym for? CHARLIE AUSTIN: Prostate specific antigen. Let’s talk about what that test is and the value of it, and why it’s so important for CHARLIE AUSTIN: It’s a blood test, and it’s not taken from your prostate. We have to remember, as we educate men about these myths, to get rid of these myths, it comes from your arm. It’s a very simple blood test. It measures the exact amount of the antigens that your prostate is producing to fight a certain level of cancer in your prostate. So if you know what that number is, you know about what degree of cancer you have in your prostate. A normal level is 0-4. My PSA, prostate specific antigen, was 600.5. Off the scale. So when that number came back, we had to get a biopsy. And the biopsy confirmed what we know, we suspected on the PSA. That’s two tests: the PSA, a simple blood test, the biopsy tel s you exactly what it is and what type of cancer it is and how fast it’s growing and spreading. A PSA is so simple. I don’t know why men don’t get them all the time, every year, once a year. After what age do you think a man should get a PSA? CHARLIE AUSTIN: If you’re an African-American male age 40 or above and there’s cancer anywhere in your family, get a PSA every single year. You should know your number. If it starts to climb, you may have a problem. It may not always be cancer, though. I don’t want to scare people into thinking that they’re going to have cancer because they have these symptoms, or the PSA number is a little high. It could be just a benign enlargement that’s taken care of very easily. Charlie, did your doctor review the PSA test? Did your doctor talk to you about CHARLIE AUSTIN: My doctor, Frank McGovern, was like – if I could find the best urologist in the world, that’s him. Took the time to explain to us every single thing he was doing. But that’s after you’ve been diagnosed. You’d been to the doctor, you’d had a stroke a year before. Had you not been – CHARLIE AUSTIN: That’s a good question. If I had been PSA tested while I was being treated for my aneurysm and stroke, maybe we could have caught it earlier. Maybe. Maybe we could have caught it It makes me wonder why, if you and I now know this, why – CHARLIE AUSTIN: It should be routine, that’s what I think. I think every hospital, when they check an African-American male in at 40 years old or above, they take a TB test, they take a test for smallpox, they take a test for everything – why not run a PSA? And let’s talk, while we’re at it, about the value of early detection. CHARLIE AUSTIN: If you get it early, and you know you can contain it in the prostate, you have many different options of treatment. You don’t have to have surgery all the time. There are radiation methods that they can do with isotopes, or you could have straight radiation, or you could have what I had, which was a combination of radiation and hormonal therapy. The hormonal therapy is an injection of a drug called Lupron, and I took some pills called flutamide for the first two months, a double dose of hormonal therapy, which basically chemically castrates you. It eliminates the fuel for the prostate cancer. Once you get rid of the fuel, and you reduce the tumor, which was about the size of a grapefruit, down to about the size of a lemon, then you get external beam radiation, very aggressively, for 38 sessions, and get rid of it. I’m now in remission. OK, you said that you were chemically castrated. Does that mean you are now Is that permanent? What the doctor tel ing you about that? CHARLIE AUSTIN: There’s not that much data on men who have been treated for prostate cancer at the level that I’ve been treated at, because there’s not too many of us around right now, unfortunately. So you’re beating the odds right now today by being here. CHARLIE AUSTIN: Absolutely. My PSA was over 600. I was like, walking around saying, So why am I here? Because I want to get the word out. So, with respect to the effect of all the therapy that you’ve had, you’re impotent, you said that you’ve gained some weight – what are some of the other aftereffects? CHARLIE AUSTIN: The side effects of the medication I’m on are mood swings, weight gain – I’ve gone up about 20 pounds, another size, I’m not going to tel you what size my waist is – and the hot flashes. I know what hot flashes are. I’ll break out in a sweat, I’ll have my own private little summer every now and then, and it’ll go away, and it’ll come back and go away. I’ll have sweats during the night. So there’s a drug I take to counteract the hot flashes. Then I take another drug to get rid of the fluid in my body that’s building up. There’s no pain associated with any of this right now. The treatment that you’re going through for advanced prostate cancer these days, there’s no pain associated with it. The only pain is missing the diagnosis, letting the systems go beyond, and then the pain of knowing that you could have, would have, should have stopped it earlier. People might hear the aftereffects of therapy, and we all know how denial works, they don’t want to know about it. They don’t want to know about it, because then they don’t have to face that. And that’s nuts, because you can survive this cancer. And I believe prostate cancer is notoriously a slow-growing cancer, so you can catch it, it’s a cancer that can be caught early. CHARLIE AUSTIN: I don’t know what the numbers are for young men between the ages of 50 and 60, but I suspect, and I really do believe, because I’ve been contacted by scores of young men, black and white, who’ve had their prostate removed because they had a PSA of 5 or better and it was starting to spread. When you’re that young, it spreads very rapidly and aggressively, so you’ve got to go in and get rid of it real quick. The death rate from prostate cancer in the United States this year: 41,400 men. 317,000 men will be diagnosed with prostate cancer this year. 1,000 men in Massachusetts will die from it. And you know, I believe that a lot of those deaths could have been avoided by just going in once a year, having your PSA, getting to know what your doctor is telling you, and understanding where You told me earlier that when you go on a story, that you’re really in their face, CHARLIE AUSTIN: If somebody asks me, How are you feeling? I’ll say, if I see him as a black male over 40, I say, I’m feeling fine, what’s you’re PSA? Do you know your PSA? What’s a PSA? Public service announcement? It’s a very simple blood test, my brother. Go get it done. It’ll save your life. CHARLIE AUSTIN: No. It’ll save your life. I should say that we are going to give a telephone number at the end of the program that you can cal to find out where in the city you can get a PSA. So Charlie, you just go out there in the street, and anybody who comes along, you now have the right, after being on this program, of really putting it home. Your recovery is medical, but I know you as a very spiritual man too. Can you tell me what role that’s playing in your recovery, for you and for the family? CHARLIE AUSTIN: A very significant role. When my wife and I attended chuch in Roxbury during the middle of this crisis, just to visit and then go back to our home in the suburbs, I felt a genuine connection with my Lord. People laid hands on me, they spoke to me, they cared about me. They got deep into my soul and said, You know, we’re praying for you, we care for you. That’s energizing, Jeanne. That gave me some more strength to keep going. We have it every day, we take charge and And how do you maintain that? When was that that you did that? CHARLIE AUSTIN: A year ago, as a matter of fact. May 2 I was diagnosed, June, the end of June we went into church and came back with a wonderful, powerful feeling of strength to win. And I was only one month into treatment at that time, having no idea what the side effects were really like, until I woke up one morning on my knees in a cold sweat, because the hot flashes just hit me. I was wondering, what is this? Another message, God? I got the first one, OK, here’s the second one. Don’t give up, stay on target, and let people know you can beat this thing, if you’re smart enough. How do you maintain that spiritual connection on a daily basis? Do you have a routine, or is it just part of your being every day? CHARLIE AUSTIN: Every morning at sunrise, I think about doing my tai chi lessons, on occasion I do, just to focus and meditate. But I read a daily word, watch the sunrise, listen to the birds, understand what’s going on around me, very slowly get in touch with my body, and then turn on the TV very low. I don’t want to rush into the day, I just want to take my time and connect and thank Him for keeping me here and giving me strength to go on. Very simple start. You don’t want to get up and start the day like, I gotta get here and get there. I don’t know how much stress was involved in my prostate cancer. I don’t know how much food was involved with my prostate cancer. Diet – high fat, those kinds of things – I don’t know. But I know if I start the day taking a lot of that crap away and focus on why I’m here today, I Why don’t we all do that, right? Did you do that before this, or is this – So often, when people are facing their own death or are brought face to face with their death, it changes how they look at life. Do you feel more appreciation for life now? CHARLIE AUSTIN: Absolutely. I have a brand-new grandchild on the way, number two. His name is Austin Jeremy. And my granddaughter, Amy – when you see an extension of you life beyond your children, to your grandchildren, it’s like, there’s Aunt Evelyn in that little three-year-old, or there’s Uncle So-and-so. That makes you want to stay around a little bit longer and enjoy life. How do you think in just your day-to-day interactions that you are different CHARLIE AUSTIN: I have to constantly apologize to people sometimes, because I’m saying things CHARLIE AUSTIN: Because of the medication. I know there’s side effects, and the studies haven’t all been completed yet, with the mood swings, and I have a very short fuse. I used to be able to take stuff for a long time before I lost it. But in the information compacting environment that we’re working in every single day, I just don’t have the stamina that I used to have, and that’s frustrating. Help me understand this. Is it because physically you’re depleted, or is it because the medicine inside of your body is – because you made sort of a fast shift here now from feeling a greater appreciation for life to now you’re feeling more impulsive, I think is what you’re CHARLIE AUSTIN: That’s what’s happening. I love what I’m doing. I enjoy life more. However, when mundane things show up, things that could be taken care of very simply by doing this and that, and then something else is added and there’s another layer and another layer, I don’t handle those stress factors as wel as I used to. I know this. There’s a new me. I’m going into therapy for it. I have to understand, because I was only one year out from the stroke and the aneurysm, and anybody who’s recovering from and aneurysm will tell you that you spend a lot of time trying to find out who this new person is in your body. I was just identifying that person, and then the prostate cancer came. So I’m in between people right now. And many times I find myself leaving the compassion and understanding of people that I should have, and I go to the anger and rage of what I’m living with. Prostate cancer survivors have conflicts constantly, because a hangnail could be more, a small cold could be something else. There are layers and layers of stress that you bring with you in trying to cope with this. I appreciate your saying that you’re going to be doing some therapy. I think that’s another obstacle that people have, they just don’t want to reach out for help. CHARLIE AUSTIN: If you know that you have a spiritual base to hang on to, to get started, and then something comes in and washes that away temporarily because you’re waiting for the next shoe to drop – I don’t know how long I’m going to be in remission. Now I am. But when I have a pain or an ache or something else that goes on in my life, could it be cancer coming back? Could it be something else? So once you get this damn disease, you’re always in the fright of saying, What’s that? Why can’t a hangnail just be a hangnail? You know? So those are the honest kinds of frustrations and things that Wel , we admire you so much. I always did in the newsroom anyway. CHARLIE AUSTIN: I’ve been humbled by so many people who keep saying that. Well, you know, you just have to sit there and listen to me say it. You just have such a class and a presence, and you’re just so wonderful, and everybody loves you, and we wish you the very, very best. We’ll be praying for you and we know that you’ll keep up the fight and that you’ll continue to do so much good. We really want you to keep getting strong, reaching out and getting the message out too. Charlie, let’s just take one minute before we sign off here to remind people about the PSA test. Go ahead and do your thing, because it’s a powerful message. CHARLIE AUSTIN: A PSA is a prostate specific antigen blood test. They take the blood from your arm and they look at it, and it can tel you whether or not you have prostate cancer. Do it every year, eliminate the fear, you’ll know how long you can live. If you ignore it, you let it go by, and you don’t go see the doctor until the symptoms get too big, it’s going to be too late. A PSA is not a public service announcement. Prostate specific antigen. A simple blood test from your arm, not from your prostate, OK, and we have a number we’re going to put up on the screen, and I’m really glad the number is easy to memorize. If you want to get this test, this is the number that you cal . The folks on the other end of this line will tell you where you can go within the city of Boston to get this test. Say Charlie sent you. 638-6767. And as Charlie said, it’s a test that could save your life. Charlie, we send you all of our love and our prayers, and thanks for coming in. CHARLIE AUSTIN: Thank you for the opportunity. We want to thank you for joining us for this special edition of About Health, and About Health TV is sponsored in part by Improving health through medical education, clinical research and community service.
Compound optimization in early- and late-phase drug discovery: Acceptable pharmacokinetic properties utilizing combined physicochemical, in vitro and in vivo screens Gary W Caldwell Keywords β-adrenoceptor blockers, assays, bioavailability, The RW Johnson Pharmaceutical Research InstituteDrug Discovery DepartmentWelsh and McKean RoadsSpring House Introduction The drug discov