RadioMD Presents: Melanie Cole's Health Radio | Original Air Date: June 8, 2015
Host: Melanie Cole, MS
Guest: Kelvin Lee, MD

This is Health Radio on RadioMD Here’s Melanie Cole.

MELANIE: Lung cancer is the second most common cancer in both men and women in the U.S. In fact, according to the American Cancer Society, there are about 221,000 new cases of lung cancer each year. Recently, New York Governor Andrew Cuomo visited Havana, Cuba, and returned back to the States with this promise of a lung cancer vaccine which is called Cimavax. It’s been researched for 25 years in Cuba. We are talking today with Dr. Kalvin Lee. He’s the Jacobs Family Chair of Immunology and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park.

Welcome to the show, Dr. Lee. So, tell us a little bit about Cimavax. What is it intended to do and how long is it going to take us to find out if this vaccine actually works?

DR. LEE: Great to be on the air with you, Melanie. Cimavax is a vaccine that was developed by The Center for Molecular Immunology in Havana. Actually, the development started back in 1996. It’s a very, very interesting vaccine. I don’t think there’s another one like it in the cancer world at all. Most cancer vaccines-- as we are exploring using the immune system to fight cancers--most cancer vaccines actually target the cancer itself. They try to get the immune system to go after the cancer cells directly. Cimavax is very different. Cimavax is actually targeting a growth factor that is normally circulating in your blood that cancers, in fact, need to survive. So, instead of going after the cancer directly, it goes after a factor that the cancers need to survive. It depletes that factor out of your body and the cancers essentially starve. The CIM investigators have looked at this in lung cancer predominantly. That’s their number one cause of cancer mortality in Cuba. There are a large number of other cancers: breast cancer, colon cancer, prostate cancer and pancreatic cancer that may utilize this same growth factor. So, this vaccine not only may be useful in lung cancer but may be useful in a large number of other cancers, too.

MELANIE: Wouldn’t it be something if Cuba, who we’ve shut out for so many years, was the one to come up with this vaccine for so many of these deadly cancers-- pancreatic cancer and undetectable cancers. How long do you think it’s going to take for us to know? As I stated earlier in a report, when we’ve got MMR and tuberculosis, small pox it took a few years before we knew that these were diseases were eradicated. How are we going to know that this one is working? Will we stop seeing lung cancer? Will it work for someone that already has the genetic predisposition for lung cancer?

DR. LEE: I think this is the really exciting part of this. I think that there are going to be two ways that we are going to know. In fact, one way we already know. Our colleagues in Cuba have treated over 5,000 patients with lung cancer with this vaccine, 1,000 of them in Cuba, and they’ve just completed a very large, what we call randomized phase three study of 450 people, I believe. These people had lung cancer. They had advanced lung cancer. What they demonstrated was that in patients that have lung cancer getting the vaccine, in fact, significantly prolonged people’s survival. And, in fact, they have about 20% of their patients, again Stage 3-Stage 4 lung cancer, where the average survivor is about a year. They have about 20% of their patients who are getting vaccinated living out to five years or longer. So, it’s a significant number of people that seem to be doing well. The amazing thing about the vaccine is not only does it appear to be effective to prolong survival in lung cancer patients but it also appears to be very safe. They had little side effects from it and irritation at the site of the injection. The other aspect of it is that it’s very easy to give and it’s inexpensive. So, it’s a shot in the shoulder once a month. In the United States your pharmacy could do it. You could go down to your local pharmacist and get a shot once a month to manage your lung cancer--that simply. Even more exciting piece of it is the question of whether or not it could be used for prevention. It certainly can be used for treatment. So, safe, not toxic, easy to give, prolongs people’s survival. All good things on the treatment side. But the real question and thing that we find so exciting about it is can it be used for prevention? Not really. The idea that we would be vaccinating a five-year-old to prevent them from getting lung cancer when they are 60? I think that we would start out looking at people that are at high risk to get lung cancer. They don’t have it yet but they are at high risk to get lung cancer. People that have smoked a lot that we can now measure; people that actually had lung cancer that was surgically removed but we know that many of them have beat up the lining of their lungs and they have other spots that are going to turn into lung cancer. We know that their risk of getting a second lung cancer is very high. So, in those groups the question is can you vaccinate against this growth factor with Cimavax? Again, because it’s cheap, it’s easy to administer and it really has no side effects that we can tell, can you prevent or reduce the risk of those patients getting lung cancer? That, as a population in the United States is probably tens of millions of people. Worldwide, it’s probably hundreds of millions of people. The idea, the question, of whether or not we could use the vaccine to prevent lung cancers or reduce the risk of getting lung cancer has enormous public health implications worldwide.

MELANIE: As immunotherapy is being used, in what a burgeoning field you’re in, Dr. Lee, it’s really amazing. We do shows for so many cancer centers here and it’s just an amazing field. When do you think clinical trials might begin in the U.S. for the vaccine as a prevention? If so, you talked about once a month for treatment, would it be a vaccine that would work in the long term? Would it need a booster on a regular basis?

DR. LEE: I think that, essentially, in terms of when the clinical trials are going to start, we are already working at Roswell Park in collaboration with the CI and we are already working on the very first clinical trial. We think that the very first clinical trial is going to just be able to confirm the safety issues or confirm the safety profile of vaccine. Our suspicion is that the FDA will ask us to do those trials even though worldwide, there have been a lot of patients treated with Cimavax and its safety record has been very good in all of those patients. Our suspicion is that the FDA, as the first U.S. trial, will ask us to replicate that safety. That’s a relatively Phase one kind of trial. We expect that we should be able to get that under way within the next 12-18 months. Part of the challenge is going to be that the Food and Drug Administration doesn’t have very much experience approving a Cuban biotech product for clinical trials in the United States. We think it’s going to be a learning experience on both sides, at least of the United States. But we think that trial will be underway within a year, maybe less. Once that trial is done, and it will be a very quick trial, our suspicion is because, again, we don’t expect to see very many side effects, then the Phase Two prevention studies would be initiated as well as looking at the potential of Cimavax in other cancers.

MELANIE: That is so exciting and in just about 30 seconds, Dr. Lee, wrap it up. How exciting this is for the listeners and what you want them to hear about Cimavax?

DR. LEE: This is a potentially game changing kind of vaccine especially in the prevention context but certainly in the treatment context. So, this is a novel vaccine. I’ve never seen another one like it that has gotten this far. We are very excited about the potential of this vaccine.

MELANIE: So exciting. Thank you so much Dr. Kelvin Lee. You’re listening to Healthy Radio here on RadioMD. If you missed any of our great programs, you can listen any time on demand or on the go at RadioMD.com. Scroll around and learn something with us.

This is Melanie Cole. Stay tuned and stay well.

RadioMD Presents: Health Radio | Original Air Date: June 5, 2015
Host: Melanie Cole, MS
Guest: Stephen Wangen, ND

This is Health Radio, with Melanie Cole.

MELANIE: Millions of people suffer from the effects of irritable bowel syndrome known as IBS. Bloating, abdominal pain, gas, diarrhea, constipation; it can all be so confusing, so uncomfortable. And although the malady itself, let alone the cause, it has been notoriously difficult to diagnose IBS.

My guest today is Dr. Stephen Wangen, he is the founder and medical director of the IBS Treatment Center in Los Angeles.

Welcome to the show. So, Dr. Wangen, first tell the listeners what is IBS and why is it so difficult to diagnose?

DR. WANGEN: As you were saying, IBS is really a broad spectrum of issues. The label doesn’t really define anything too clearly because anybody who’s got diarrhea, who’s got constipation, who’s got gas, who’s got bloating, or just simply has abdominal pain and doesn’t have anything else. So, you don’t have appendicitis and you don’t have gallstones and you don’t have Crohn’s disease. If you’ve got one of those symptoms in any combination, it doesn’t matter which one you have or if you’ve got all five of them, then essentially you’re left with IBS. That is millions of people in this country.

MELANIE: Do we have any idea what causes it?

DR. WANGEN: I think it depends on who you talk to. Your typical doctor is so busy ruling out all of these other issues and making sure that there is nothing life threatening that essentially when they do that they’re pretty much at the end of their expertise. They are saying, “Well, we haven’t found anything that is going to kill you today or in the next few weeks.” Therefore, as far as they are concerned, you are essentially fine. But unfortunately, as people who suffer from these things, like I have, it’s incredibly debilitating. It affects everything that you do. It affects your ability to work, your ability to have a social life, your ability to travel and all these things that people want to and expect to be able to do is altered by these symptoms that, of course, are very, at minimum, embarrassing, but can be incredibly painful even.

MELANIE: Absolutely.

DR. WANGEN: Yes and it’s the story that I hear from patients over and over and they are very frustrated because they have been to so many doctors and they are not getting any answers and that is essentially what happened to me as well. When I had IBS 20 years ago and I had the same problem, I would go to doctors and they would say, “Well, we don’t know what’s wrong.” And I would say, “Well, this is ridiculous. There’s got to be a cause if there’s a problem. We’ve got to be able to figure this out.” What I learned over the years as I became more and more focused on this topic and then eventually founded the IBS Treatment Center, was that it was just a label that didn’t really tell you anything about the cause because there were literally hundreds of causes.

MELANIE: Yes. I’d like to narrow down some of those and talk about this blood test. I had IBS 20 years ago, too, and while I’ve had colonoscopies, they did a barium enema. There’s a pleasant test. Oh, my God. It was so painful. So, what about this blood test--because we don’t have a lot of time in these segments – but what is this new blood test that can confirm IBS?

DR. WANGEN: What the blood test might do, at least, is maybe prevent the need for some other tests. Because all of those tests are designed to rule out other things. So, if the blood test shows a positive, it is a much higher indication that you’ve got IBS, at least in the cases of people who have diarrhea with IBS. It is only valuable in those cases. It doesn’t have anything to do or help with any other form of IBS, but it gives you some indication that you probably don’t have any other problem. It really still is like a lot of tools that have been used in medicine. It’s a rule out tool. Ruling out other problems and saying, “Well, we’re left with IBS.” It’s a step in the right direction, but it really still doesn’t provide patients with a great piece of information that says, “Okay, now what do you do? Now, how are you going to solve this problem?” But it might help prevent you going through other testing that would be a waste of time, or like you said, could be incredibly uncomfortable.

MELANIE: Really uncomfortable. So, what else can you do to treat IBS? Let’s just stick with that now because treatment – I had it, mine went away. I’m not sure exactly why because Chrone’s runs in my family, but mine went away. I didn’t eliminate gluten. I stopped eating broccoli for a while, but now I can eat it again. So, what are we looking at? Is it the high gassy foods? Do you steer clear of some things that you know are triggers? Fiber supplements? What do we do?

DR. WANGEN: Well, that is the million dollar question, or the billion dollar question. When I see a patient, I honestly don’t even have a plan yet of exactly what we are going to need to do because there are so many potential problems. But what I am looking at is narrowing those down. So, as an IBS specialist, my goal isn’t to diagnose IBS, it’s to solve it. It’s to say, “This is the starting point. You’ve got these symptoms. We need to be able to solve this, so what do we do next?” That is a detective process where we say, “You could be reacting to literally anything.” You mentioned gluten. You mentioned broccoli. You mentioned all these things. Every patient is different and that’s what makes it so challenging. Especially for people on their own. They start going on diets that they heard about and it might be a thing that they need to do. They’re told, “Maybe you should go on the [inaudible 5:40] diet or maybe you should go on the [inaudible 5:41] diet. Maybe you should do this or you should do that. And they try these things and it might help a small percentage of people, but for most people, it’s actually not going to be the answer because they are going to have a completely different issue. What I have to do is take each patient individually and say “Well, anything is open to the possibility at the beginning.” Anything, it could be dairy, it could be egg, it could be soy, it could be corn, it could be gluten, it could be yeast, it could be almonds, and it could be you name it. It could be foods that everybody on the planet has told you are good for you; it could be bad for you. Plaque; it could be anything. But I have to start there and be really logical and methodical narrowing it down. The same is true with all of these other issues you hear about probiotics and you hear about candida and you hear about parasites. You hear about this whole microbial world of the gut. It is a fascinating world, but we need to understand it better. We need to figure out what a person really needs. Because I have just as many patients that feel worse on probiotics as feel better. And there are reasons for that. We need to take that at face value and say, “Well, if that’s what’s happening, I need to know that so I can do some more detective work to I can figure out why that is.” I wish there was a simple answer where I could say everybody with IBS just go do that. But that is what you are already being told. You’re being told, “Well, just go on this diet” or “Just go take a probiotic” or “Take this enzyme.” It is not going to be something that is going to be cured by a supplement or by just everybody going gluten free. For some people that is going to work great. But that is not going to work for 95% of the people who are going to try it. If there were looking for a nice quick easy pop answer I could give it to you, but in reality what a person needs is somebody who’s full focus and interest is on solving the IBS, essentially an IBS expert, who that’s their job. That’s a big distinction from a gastroenterologist whose job is to perform colonoscopies. It is to look and scope look for other problems but not necessarily to solve IBS.

MELANIE: So, if people are looking to solve IBS, do you typically, I mean probiotics certainly have been touted and trying all these different eliminations of things and stress reduction. Because I’ve heard that stress is such a big contributor to IBS. So, what do you recommend? We only have a minute left, so wrap it up for us. In your best recommendations about the importance that you think this blood test might have in getting the diagnosis just a little bit quicker so we don’t have to go through so many of those uncomfortable tests and what you think the best advice for treatment is.

DR. WANGEN: Stress is often blamed. I think what happens to people is that when the doctor can’t find anything; they get pushed in that direction of “Well, it must be stress. It must be in your head. Because everything seems to be showing up normal.” Ironically, what I find is that for most patients it’s the IBS that is causing the stress, not the other way around.

MELANIE: Interesting. We only have 10 seconds, Doc.

DR. WANGEN: Sure. I want people to do is to have hope that there is an answer. But it’s not necessarily going to be a simple, “Oh, I can pick this up off of the internet.” But keep the faith. Keep hopeful that there is something out there that is really the solution to your problem. Our website IBSTreatmentCenter.Com is full of information and stories about people who have found the answer to their IBS.

MELANIE: Thank you so much. It’s great information. You’re listening to Health Radio right here on RadioMD. I’m Melanie Cole. Stay well and stay tuned.