Dr. Franjo Vladic is a Board Certified Gastroenterologist with the Center For Digestive Health and Endoscopy Center outside of Cleveland, Ohio. He and I discussed Colorecal Cancer screening options as well as issues faced by Colorectal Cancer Patients.
Lee: Dr. Vladic, thank you so much for joining me today, and making the time from your busy schedule, I really appreciate it. How are you?
Dr. Vladic: Good. Thank you for the opportunity to speak on behalf of the Cologuard.
Lee: You’re welcome. So, the way this all came to be, back up a couple of months ago, I heard that there was going to be a story on the Cologuard on NBC Nightly News with Lester Holt. Being a stage four survivor myself, I was very interested to see any publicity we can get to increase awareness about screening is important. So, I watched the story, and they profiled a woman who I just had the pleasure of interviewing just a few days ago, Dorothy O’Shea. She talked about how Cologuard saved her life. That she lived a healthy lifestyle, vegetarian, exercise, no family history, turned 50, Doctor said here you go, colonoscopy time. She said, I don’t really want to do that, based on all the information I just shared. So, he offered Cologuard. It came back with a positive test, and she said it saved my life. What’s been your experience with Cologuard, and who is right for that product?
Dr. Vladic: My experience has really been also a very positive experience with Cologuard. The individuals who are right for Cologuard actually are those patients who present for routine colon screening. What we mean by that are, these are eight individuals who are fifty and older, men and women, and they have no symptoms. Meaning, they’re just coming in, just for a routine evaluation for screening. Furthermore, the Cologuard at this time, the FDA has not cleared it for people with high risk backgrounds. Meaning, those who have a family history of colorectal cancer, those who have a personal history of polyps, and those who have inflammatory bowel disease, either Crohn’s Disease or ulcer colitis. So, those individuals would be excluded from the Cologuard at this time. In the future, we’ll see what happens with that. For now, those are the individuals, so it’s basically asymptomatic, individuals fifty and older, men and women that it’s recommended for.
Lee: Do they also recommend not including people in the immediate family who have shown a history of colon cancer?
Dr. Vladic: That’s the family history so it’s the first degree relative. Whether it’s a sibling, Mother, Father, and the significance of a first degree relative would be that individual that is sixty years or less. If you have a first degree relative, that’s above that age limit, you’re considered average risk. It’s only sixty years and older in a family member that’s considered at high risk, and that would exclude you.
Lee: That’s good to know because being involved in the Colon Cancer Alliance, particularly, their very active Facebook group called Blue Hope Nation. I see so many stories of survivors saying I’m struggling getting family members to get screened. So, as long as it’s not an immediate family member, from what I’m understanding from you, if it’s a cousin, or a little bit further, a distant relative, as long as they meet the guidelines, Cologuard could be an option for them.
Dr. Vladic: Exactly. The key word that you used there, it’s an option. I mean, what I like about it is you know, there’s no one specific test that’s perfect and the best example I can give is as I tell my patients, the best screening test is the screening test I can get you to do. So, in my office when I see patients, whether they choose to do Cologuard or a colonoscopy, doesn’t matter to me, as long as they choose one or the other, and I can get that individual screened, I’ve accomplished my goal.
Lee: What are the latest statistics as far as the success rate of the test?
Dr. Vladic: Well, I mean, before they even got the indication approved, meaning by the FDA, which is the food drug administration, and the CMS, which is the one that governs the Medicare. Those two body agencies had to have all the data submitted by Cologuard. Cologuard did do a study, and they were able to also have it nice and published, in the New England Journal of Medicine as well. That showed basically that the rate of Cologuard finding, meaning those patients who had a negative colonoscopy who did not need a biopsy, the specificity of Cologuard was 90%, so it correlated with that colonoscopy finding 90% of the time. Consequently, that is a very good test outcome with regards to that. With regards to what does it look for, the key thing here with Cologuard is, there’s two things that it looks for. One is it does still look for the blood component, so it will look to see if there’s blood in the stools. That’s what any other tool testing does. Then, the other thing it looks for is, the characteristics of these DNA bio markers, for either colon cancer or colon polyps. Patients sometimes will ask me, well, how do we know that this is a sufficient sample? They also look to make sure that there’s a normal amount of DNA bio markers in there as well. If there isn’t, that is, if there’s an insufficient, the company will then ask for a re-do of the Cologuard testing, and what’s nice about the re-do is the patient is not charged an additional fee because they’re redoing it. You only get charged one fee. That’s the key thing that allows this test to be a sensitive and specific, to comparability to the diagnostic colonoscopy as well.
Lee: Take us through. Should someone use Cologuard, and the test comes back positive, where do they go from there?
Dr. Vladic: So, the question I get asked by patients is, when I do have a positive result, they ask me, what does this mean? When you look at the data on Cologuard, what does a positive test mean? So then, that individual who gets a positive test will undergo further follow-up testing with the colonoscopy, which is the indication. So, anybody who has a positive Cologuard then merits a colonoscopy. If you look at the data that was published in the New England Journal of Medicine, 2014, those patients who had a positive and then underwent a colonoscopy, 45% of those had a negative finding, meaning the colonoscopy was negative. 31% had what we call a non-advanced edanoma, or polyp, that did, it was present, there was a polyp, but it was not a type of advanced one, meaning it was less than one centimeter in size, it did not have any, what we call, dysplastic cells. Another 20% had advanced edanomas, and that could be, either a large polyp one centimeter or higher, or advanced dysplasia, which is abnormal cells meaning really close to the next step of forming colon cancer. Only three point seven percent actually had colon cancer. You have to remember, we’re doing Cologuard in people who are asymptomatic have no symptoms, so consequently, that percentage is pretty acceptable. Meaning, that’s what you’re going to see about 3.7% cancer detection. The other flip side is, you know, patients will ask me, when I have a negative test, how certain can I be that there is no colon cancer present? In that same New England Journal of Medicine, those who had a negative Cologuard test and then underwent a colonoscopy, there was only 0.06% cancer detected. Basically meaning that if you have a negative result, the chance of having colon cancer of you having, colon cancer, is 99.94% of being negative. There’s no colon cancer.
Lee: I’ll take those odds.
Dr. Vladic: Yeah. So, basically, you also have to compare it, and I think when I have these conversations with patients, people tend to forget. When we do a colonoscopy, and if you look at the literature, there is a miss rate. Meaning, when you have a colonoscopy, there is a percentage of polyps or cancers that are missed with the colonoscopy. It’s no fault of the gastroenterologist, meaning they do a thorough job, but there are folds in the colon, and when you’re doing a colonoscopy, the colon does not stop moving. Your colon still has the motility. So there’s a chance that they can miss something, gastroenterologists, and the literature reports that at 5%. Even when you’re doing a colonoscopy, there’s a chance of missing a colon polyp or colon cancer at 5%. Same with the negative test results of Cologuard, which is, I gave you the percentage of missing cancer, when it’s a negative test, it’s a 0.06, but it can miss a polyp, which is an advanced polyp, meaning advanced, meaning larger size. 5%. If you compare Cologuard and Colonoscopy, you’re at the same percentage. 5% chance of missing it. So both tests are very equal in colon screening.
Lee: Interesting. What are you thoughts, what’s your reaction, I guess I should say, to the publicity and the advertising that Cologuard is. Is it your hope and expectation that it’s going to impact the screening rates?
Dr. Vladic: It’s a three fold answer to that, I think it’s going to impact it, and the three reasons that I believe it’s going to impact it. The first reason is, you know, there are a lot of patients who A) for whatever reason, are fearful of colonoscopies, or they don’t like the idea of having to do a colon prep for the colonoscopy, which this colon guard alleviates, there’s no colon prep. The Cologuard is just a spontaneous bowel movement, and furthermore, some patients cannot find someone to drive them for the tests. For the colonoscopies, when you’re undergoing sedation, you need to have a driver. So, this makes it a lot more appealing to patients to get. That’s one reason. The second reason too, is, there are areas in this country that individuals are not that close to medical access. There are places where sometimes patients are 300 miles away from the nearest gastroenterologist. The nice thing about Cologuard is, they’ve come up with a way of alleviating that burden to the patient. Cologuard has an association or contract with the UPS, and basically, the Cologuard, when the physician orders it, Cologuard is brought to the patient. The patient does not need to go anywhere. The UPS brings that box, with all the contents in there, with the instructions. The patient performs the test at home, then they call UPS, which has a pre-packaged label, already labeled. They call it. UPS comes to the person’s house and picks it up. So, that alleviates you know, any concerns of location of patients to medical care access. Finally, I think the big thing is, as we talk about in this country, the cost of healthcare. Everyone knows that the colonoscopy is not cheap. The list price for Cologuard is $649. That’s why CMS and FDA really approve this product in particular. CMS, which deals with medicare. This is a cheaper alternative to get all these individuals screened or under medicare. This is much cheaper for the healthcare industry and the medicare to do Cologuard than a colonoscopy.
Lee: Interesting. Well, based on those three reasons, certainly, I know the hope is that bottom line is that we get more people screened. You know? We see the statistics that are out there, and you know what we know about colon cancer and early detection. That’s the hope that that’s where this will wind up, having this kind of impact.
Dr. Vladic: Yes. That’s the goal.
Lee: Certainly. So, I spoke to a few of my fellow colon cancer survivors, and told them that you and I were going to be spending some time together. They said, if he has time, see if he would ask some of the most common questions that are out there in the colon cancer community. So, I appreciate if you could let me go through a few of these, and get your thoughts. The first one is, and I’ve personally experienced this, as I’ve interviewed so many people on the colon cancer podcast who were diagnosed younger than 30. The common theme is that their primary care physician didn’t take their symptoms or their personal complaints seriously. Are you seeing anything happen out in the medical community to enhance education around a young onset of colorectal cancer?
Dr. Vladic: I think with regards to taking, you know, the patient’s symptoms serious. Unfortunately, that is something that, regardless of colon cancer, in general, for any symptoms that patients present with, the physician needs to be aware of what the alarm symptoms are. What I mean by that is, in particular with GI symptoms, especially in young patients. I always like to tell people, if there’s blood in the stools you’re seeing, you have unintentional weight loss, you have abdominal pain, that in particular wakes you up during the night. You have this recent change in bowel habits, from your baseline, whichever way it may be. It’s a change for you from your baseline. I really believe that those individual patients merit an evaluation. It doesn’t have to be that, per se, they have colon cancer. Other conditions, and particularly young people, you have to really consider inflammatory bowel disease. Like, Crohn’s disease and ulcer colitis. In my practice, even if they’re young and they have any of those alarm systems that I mentioned previously, I recommend to those patients to get an endoscopy evaluation for further investigation before we attribute it to saying it’s nothing to worry about or it’s benign, you know, you don’t have to be concerned about it. That’s how I practice. I try to get that out in the community with the primary care doctors as well.
Lee: I see. What are your thoughts on the impact of both diet and exercise in the prevention of colon cancer as well as post diagnosis?
Dr. Vladic: There are articles published with regards to, when you look at the obesity epidemic, and the risks with obesity. One of the things that’s listed with obesity is, that the individuals who have obesity are at increase for cancers. It’s not per se just colon cancer but in general. Cancers. There is a part in play that diet and exercise are important, and that’s just extrapolating the data from the obesity data that’s out there. Consequently, I think that is important. With regards to specifically what diet is, is there a specific diet that’s out there, whether it’s the Mediterranean diet, whether it’s the Celiac type diet or any of those. I don’t know if we have any definite data that can diet program is better than another one. I do think a healthy lifestyle, including a healthy diet, eating a balanced group of foods and exercise do benefit the individual in general.
Lee: On the last question that comes up is those folks who have had to have an interior re-section. As you know, there’s a lot of post surgical I guess they actually refer to it as low interior re-section syndrome. Anything that you’re aware of that has been found to help people that are dealing with that?
Dr. Vladic: That’s one of those that I think, not only for the surgeons, in particular the colorectal surgeons, and the GI doctors. It’s a tough one to take care of patients and as much as it may be frustrating for the patient, I can say that it’s also equally frustrating for the physician trying to take care of those patients. It’s difficult unfortunately.
Lee: Well, Dr. Vladic, I really appreciate you taking the time from your busy schedule to talk with me. I know that those who follow the colon cancer podcast also appreciate you sharing this information with the community. Thanks for spending the time, and I appreciate it, and I want to wish you well.
Dr. Vladic: I’d like to thank you guys for giving me that opportunity.
Lee: Terrific, it’s our pleasure, you take care.
Dr. Vladic: You too.