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Are you curious what can biologics do for your Crohn's disease symptoms and progression? Get an expert's opinion on what's possible and recommended for treating Crohn's with biologics.
Join us for an in-depth discussion of how biologics are revolutionizing Crohn's disease treatment. You'll find out if you're a candidate for biologic therapy, how biologics work in your body and how they may improve your quality of life. You'll get tips on what to ask your doctor before starting biologic therapy, plus hear the latest clinical trial and treatment news.
As always, our expert guests answer questions from the audience.
Rick Turner: Hailed as miracle drugs for some, biologic treatments can drastically improve the lives of people with moderate to severe Crohn's disease. But some of the information about these drugs is still vague. For example, why do they work for some and not others? How serious are the side effects really? And will new and better treatments become available soon?
Well, our expert guest, Dr. Gil Y. Melmed – who is currently in private practice at Cedars-Sinai and clinical instructor of medicine at the Cedars-Sinai Inflammatory Bowel Disease Center, part of the David Geffen UCLA School of Medicine in Los Angeles – will give us some straight talk about biologics and answer your questions about these revolutionary treatments.
Dr. Melmed, thank you for being here. Welcome to the program.
Dr. Gil Y. Melmed: Thanks very much, Rick. Pleasure to be here.
Rick: Great. Let's start off with a broad question about Crohn's disease, because I imagine most of our listeners are very experienced with Crohn's because they live with it or care for someone who does. But for those who don't know so much, who are new to the illness or our webcasts, describe for us what Crohn's disease is and its symptoms.
Dr. Melmed: Sure. Well, Crohn's disease is basically an inflammation of the gut. Inflammation we think of as sort of like in arthritis we have inflammation of the joints causing pain. We have inflammation of the gut in Crohn's disease, and the gut is really anywhere from the mouth all the way down – 20 feet of gut, intestines, stomach, colon, down to the anus, and it can affect anywhere. We're not really sure what causes Crohn's disease, but we believe that it relates somehow to people's genes as well as their environment and also their immune system.
The symptoms that can result from inflammation in the gut can include diarrhea. It can include abdominal pain, particularly when inflammation over time leads to narrowing that are called strictures. These strictures are the result of long-standing inflammation when it is probably undertreated or not treated over time.
Rick: So the piping becomes clogged.
Dr. Melmed: Exactly.
Rick: Now, you mention the immune system, Dr. Melmed. Are we sure that Crohn's is an autoimmune disease, that is to say it's caused by something going haywire in our own immune systems?
Dr. Melmed: Autoimmune is a difficult concept to get one's head around. We don't believe that Crohn's is exactly the typical type of autoimmune disease where part of the body seems to attack another part of the body. But it does seem to be a disease where the immune system is involved in a way that is abnormal.
In a normal, healthy person who is not affected by Crohn's disease the way the immune system works is, it is always ready to find something that is going on in the gut to respond to – for example, a bacteria or an infection – and then that immune system revs up, deals with that infection, fights it off, and then calms down afterwards, going back to a state of being normal. So that's why, for example, with a state of food poisoning people might get symptoms of diarrhea, abdominal pain, but that will quickly resolve once that infection is dealt with.
In Crohn's disease, however, there seems to be some defect in that on/off switch, and the immune system is turned on by some trigger, we're not sure what, and has a very difficult time in turning itself off. That inflammation just goes on and on and on.
Rick: That leads me to my next question. We had a listener, George, from Sarasota, Florida who sent us an e-mail asking, "Does Crohn's disease ever disappear?"
Does it ever just go away on its own, Doctor?
Dr. Melmed: It's possible. I won't say, no, it never goes away on its own. The immune system and the body do things that we don't quite understand. Just like we don't understand what turns the inflammation on necessarily, there are things that turn the inflammation off, and it's possible for Crohn's disease to go away by itself.
However, we do know from large studies that have looked at large numbers of people affected by Crohn's disease that it is a progressive disease over time, meaning that it continues and actually can get worse, and untreated disease can lead to complications. So we generally think of Crohn's disease as a life-long illness, a chronic illness, unfortunately.
Rick: Yeah. So don't plan on outgrowing it.
Dr. Melmed: No. I wish it were that easy.
Rick: Yes. Now, the topic of this webcast is the biologic treatments, the newest wave. But before we get to describing those specifically, tell us about what has come before the biologics, the nonbiologic treatments, the more traditional approaches to treating Crohn's disease.
Dr. Melmed: We have traditionally thought of treatment of Crohn's disease in the picture form of a pyramid, kind of like the old food pyramid. At the bottom of the pyramid are those treatments which are believed to be safer but probably less effective, and that first, basic level of therapy for Crohn's disease would correlate with the more mild type of Crohn's disease, in theory. That level might include medications such as ASA products, which people might know as Asacol, Pentasa or Lialda [brand names of the drug mesalamine] or Colazal (balsalazide). These are also available in suppository or rectal enema form.
These medications coat the gut from the inside and seem to quiet down the inflammation, although, like I said, they are at the bottom of the pyramid, and they might not be so effective for more significant disease.
Also at the bottom of the pyramid are antibiotics. For some reason – and we don't know why – but some people do seem to respond to antibiotics that will improve and quiet down the inflammation.
If people don't seem to do well with that level of therapy, in that bottom of the pyramid, the next level up is what we would consider immune modulating therapy. And the first type of treatment that someone might get at this level would be steroids, or prednisone, which has traditionally been the first treatment of choice for someone with an active inflammation because they work quickly.
Rick: Right.
Dr. Melmed: On the other hand, steroids have a lot of side effects, short-term and long-term, and we don't like to put people on these medications for any longer than necessary. Someone who's declared a need for steroids will generally be transitioned onto a longer acting immunosuppressive medication such as Purinethol (6-MP or mercaptopurine) or Imuran (azathioprine) or methotrexate. These are considered all nonbiologic treatments.
A step up from that sort of level of therapy would be the biologics in the way most people approach the management of this disease.
Rick: So, big picture, how are the biologics different from all those other approaches you just described?
Dr. Melmed: The primary way biologics are different is that they are specifically crafted and engineered to target a very specific mechanism of inflammation. An analogy I like give is, steroids you think of like a nuclear bomb – they completely shut down the entire immune system and lean to suppress inflammation in that way.
A biologic treatment, on the other hand, is like a laser guided missile. It's targeted specifically against one specific chemical in the immune system that drives the immune system to be active. In the case of some biologics that chemical is called TNF-alpha, and biologics are therefore very, very specific with the idea of knocking out that key player, that key messenger and thereby quiet down the immune system without all the collateral damage that might be found in steroids right now.
Rick: The smart bomb approach.
Dr. Melmed: Exactly.
Rick: So describe for us what the biologic therapies currently available are, and since there are more than one, how they're different from each other.
Dr. Melmed: Well, I mentioned that chemical, TNF-alpha, that's involved in a critical way in driving inflammation in the body. The two available biologic therapies are Remicade (infliximab) and Humira (adalimumab). Both of these biologics are created and designed to specifically target that chemical, TNF-alpha, so we call them TNF blockers or TNF alpha inhibitors. Remicade and Humira are very similar to one another, but there are some key differences. Remicade, which is the first one that was invented, is composed about 25 percent mouse protein and the remainder is human as opposed to Humira, which is fully humanized.
Rick: Then we have something called Cimzia. Is that available yet?
Dr. Melmed: Yes. There is a third TNF blocker on the horizon. It's not currently FDA are approved, but it may be in the next few months. Cimzia (certolizumab pegol) is about five percent mouse protein and seems to work very similarly to Remicade and Humira, although there are some structural differences in Cimzia that may or may not eventually pan out to make any important difference in the way the drug is used. But we believe that Cimzia, assuming it will be approved and hopefully it will be, will be a third anti-TNF option for our patients.
Rick: And for the purposes of this discussion, the patients listening, what's the difference between a fully humanized protein and one that has mouse protein in it?
Dr. Melmed: The main difference is in how one's body might react to that mouse component. As far as the protein itself doing what it's supposed to do, there really isn't a difference that we've seen as far as how effective those drugs are. They all seem to be equally effective in controlling the inflammation. The difference arises in how one's body might react, how one's immune system might react to that mouse component because it's a foreign protein and our immune system is out there to try to protect us against foreign invaders, so to speak. Remicade, being a partial mouse protein, some people's immune system might recognize that as foreign. That could in turn potentially lead to reactions against the drug or effectively knock it out of the system to make it less effective over time.
Rick: But it depends on the individual how they're going to react, right?
Dr. Melmed: Exactly. And it also may depend on other factors involved, such as what other medications people are on.
Rick: Right. So we described the anti-TNF approaches, the biologics Remicade, Humira and Cimzia. There's another biologic called Tysabri, which I understand has a different mechanism. Describe that for us.
[Medical Editor's note: Since this program was broadcast, a third biologic was approved by the FDA for the treatment of Crohn's disease, which is called Tysabri (natalizumab). Tysabri was approved on January 14, 2008 for the treatment of adults with moderate to severe Crohn's who have had an inadequate response to, or cannot tolerate, traditional therapies including the anti-TNF products noted above.]
Dr. Melmed: The analogy I like to give for Tysabri (natalizumab) is – again, as you say, it's a completely different mechanism of action. Part of the immune system are white blood cells that are floating around in our bloodstream sort of looking for an outlet from that bloodstream into the various organs that we have to contribute to inflammation, and again reminding people that the inflammation in a general sense is a good thing because they're there to protect us.
The way Tysabri works is that it effectively blocks the exit of these white blood cells into the gut or into the colon where inflammation is most prominent in people with Crohn's disease. So if you think about these white blood cells driving down the freeways, the arteries in our body, Tysabri would block the exit that's leading off to the gut so that these white blood cells just can't get there to cause the inflammation.
Rick: So how effective have they been? We've got those four different approaches with biologic therapies. Have they shown promise and effectiveness in managing the symptoms of someone with moderate to severe Crohn's disease?
Dr. Melmed: Indeed they have, and that's very exciting for doctors who treat inflammatory bowel disease to have these biologics as options for treatment of the illness. Studies have shown short-term very impressive results of up to 80 percent of people responding very favorably to the drugs. Long-term, out to a period of about a year, that response is a little bit less, but it seems that about 50 percent of people still feel very well after starting these treatments, with about a third of them in complete remission, which is to say that the inflammation is essentially gone, and their symptoms are down to normal.
Rick: So are those numbers big steps forward from what we used to get from more traditional approaches?
Dr. Melmed: Yes, they are.
Rick: So why don't they work for everyone? If we understand the mechanism involved and we understand how these biologics interrupt that mechanism or whatever they do to knock down the inflammation for people, why don't they work in everyone? Do we know why?
Dr. Melmed: Well, that's the million dollar question. I think if we knew why, we would be able to target appropriately which patients get which drugs to maximize the effectiveness of this therapy. There are some clues that we have. Even though TNF seems to be a critical messenger in driving inflammation in the gut and elsewhere in the body, it's not the only pathway. So some people's Crohn's disease may be the result of inflammation driven by other pathways that are not primarily TNF driven, and that may be why those people don't respond.
Other people may have genetic or immunologic factors that are specific to them or their disease that may also prevent an adequate response to these drugs.
Finally, there may be environmental factors that also may inhibit or prevent adequate response to this drug. For example, smoking has been thought in some studies to prevent an adequate response to Remicade.
Rick: And as you say, we're still at the point, unfortunately, where a doctor can't look at a patient beforehand and say, "I know which biologic is best for you."
Dr. Melmed: No, unfortunately we're not there. I think maybe five, ten years from now we'll be able to do a blood test of a panel of perhaps certain genes and, say, based on your genetic profile or based on your immunology profile we can tell you that your chance of responding to this drug is X, and therefore this is or is not a good choice of medication for you.
Rick: Right. Okay. So we know how effective they are, a big step forward. I'm sure a lot of people are worried about the downside. What are the side effects of each of these biologics, Doctor?
Dr. Melmed: Sure. Well, the side effects can, I think, be grouped into those that are more common and those that are significant but a lot more uncommon or rare. As far as Remicade is concerned, and I'll just start with that, there can be reactions as I mentioned before due to the mouse component that may manifest as allergic reactions either at the time of infusion of the medication or several weeks afterwards. In addition, over time those reactions can become more severe over repeated exposure to the drug. But a true life-threatening allergic reaction to this medication is very, very rare.
Other reactions that relate to all of these medications primarily involve infections. We're dealing here with drugs that affect the immune system, and the immune system is important in protecting our body from infections. So any tampering with the immune system is going to increase that susceptibility to infection. For the TNF drugs one infection that received a lot of notoriety is TB, tuberculosis. And for this reason it's important to be tested and checked for TB prior to initiating the drug. In fact the companies for these medications mandate that a normal TB test be documented before starting the medication.
In the case of Tysabri there is a specific infection that was uncovered in the clinical trial which is very, very rare but can be deadly. That infection is called PML or progressive multifocal leukoencephalopathy related to a virus in the brain. Even though this infection, again, is very, very rare – three out of several thousand patients came down with this infection – as I said it can be deadly. So infections are something that we do need to be careful of and watch out for in the use of these medications.
Rick: And what about the issue of lymphoma?
Dr. Melmed: Well, lymphoma is a hot topic with regards to Remicade and Imuran, the TNF drugs. There have been some very large studies that have looked at this question now that these drugs have been out for over a decade now. There's over a million people around the world that have used Remicade, and we have a lot of accumulated experience. For these very rare side effects it's hard to find specific numbers in small clinical trials, but over time when you have large groups of people who've been exposed to the drugs, we can begin to learn about these risks.
With regards to lymphoma, a large study was published last year which looked at people who had been exposed specifically to Remicade with Crohn's disease and actually didn't find that Remicade by itself was an increased risk factor for lymphoma. On the other hand, some other large studies have suggested that it might be a risk factor for lymphoma.
When we talk about lymphoma, though, it's also important to understand that there are different kinds of lymphomas, and most of these lymphomas related to the TNF blockers are typical lymphomas which are readily treatable. There is however a rare form of lymphoma called hepatosplenic T-cell lymphoma that was uncovered recently and found to be associated with use of Remicade together with other drugs, such as Purinethol (6-MP or mercaptopurine), Azasan (azathioprine) or Imuran, that is a lot more serious than the run-of-the-mill, usual lymphoma. This particular lymphoma seems to affect younger people, and it can be deadly. So because of that, there's now a new warning on the use of Remicade, and doctors have really had to have significant discussions with patients about the risk of lymphoma and the use of these medications.
Rick: So with all of these concerns about these potential side effects, and you describe some of them as being very rare and others are more common, how concerned should people be long-term? And especially for younger people, for children, are they at a greater risk of any of these side effects given that they're going to be on these treatments for a longer time?
Dr. Melmed: Well, that's a great question, Rick, and I wish I knew the answer to that. Yes, there are risks to these medications, and it makes sense to say that if you're on a medication longer, a potential long-term side effect becomes more common even though it's very, very rare.
On the other hand when you talk about children, we have to deal with issues such as growth, which are critically important in children. Children are affected with regards to their growth and their maturity not just by the disease, which can cause short stature and delayed growth, but also by the alternative medications that we have to use, primarily steroids. And these biologic agents have been shown to improve growth in children and getting them through those critical growth period years. It needs to be taken into consideration on the benefit side of these drugs at the same time as having the discussion about the potential risks.
So like with anything that we do in medicine, there's a risk to doing something, there's a benefit to doing something But there's also a risk to not doing something, not initiating a certain medication, not treating the disease. That all sort of needs to be taken into consideration together between the doctor and the patient.
Rick: Now, you mentioned that the first biologic approved for Crohn's disease was Remicade. How long has that been around? And in terms of overall evaluation over years and years, do we really know what the long-term side effects of these medications are yet?
Dr. Melmed: I don't know exactly what year Remicade was approved, but it's been around for use first in rheumatoid arthritis for about 15 years I believe and Crohn's disease about ten years.
Rick: Okay.
Dr. Melmed: So we have 10, 15 years of experience, and the studies which I quoted earlier with regards to infection and lymphoma are pretty much where we're at – these were recent studies showing that there may be this increased risk, but this increased risk is small. I suppose we're going to find out more, as these drugs are out for a longer period of time, about what additional long-term risks there may be.
Rick: I'm sure we will. Now, you mention these are protein, and people eat protein every day, right? We take it into our bodies in the form of food. So if we ingest proteins regularly, why can't we take these biologic therapies, which are proteins, in the form of a pill? Because they all have to be injected or infused right now, right?
Dr. Melmed: Yeah. One of the downsides of these medications is that they do need to be injected or infused. The problem with these being proteins is that once they enter the stomach, they get digested, like all the other proteins that we eat. So ideally I think there will be, in the future, a different kind of therapy. Certain small molecules are being developed that can also target specific parts of the inflammation cascade in the body that may ultimately act in similar ways to the ways biologics act today, but these are not quite ready for prime time yet.
Rick: And when you say "digested," that means they're broken down and no longer able to do what you want them to do as opposed to just being digested for the sake of food.
Dr. Melmed: That's right. They are digested, they are broken down. And by the time they enter the bloodstream, they are not in a form that would allow them to be active in a way that we want them to be.
Rick: Right.
Dr. Melmed, we know that Remicade and Humira have now been approved by the FDA for the treatment of Crohn's disease, but have the others not been? In other words we mentioned Cimzia. We mentioned Tysabri. Do you expect those to be approved? And are there others in the pipeline?
Dr. Melmed: Well, Rick, these are the two drugs right now that we hope will be approved. They, I believe, are both under review by the FDA. Cimzia was actually thought to be approved earlier in 2007 and has been delayed for certain reasons I'm not quite clear on, but we expect that it may very well be approved within the next few months.
[Medical Editor's note: Since this program was broadcast, a third biologic was approved by the FDA for the treatment of Crohn's disease, which is called Tysabri (natalizumab). Tysabri was approved on January 14, 2008 for the treatment of adults with moderate to severe Crohn's who have had an inadequate response to, or cannot tolerate, traditional therapies including the anti-TNF products noted above.]
Rick: Okay.
Dr. Melmed: With regards to Tysabri, during the clinical trials that were being performed for Crohn's disease as well as for multiple sclerosis, the infection that I mentioned earlier, PML, was a reason that the Crohn's studies were stopped, and Tysabri, which had recently been approved for multiple sclerosis was actually pulled off the market. Subsequently to that, the FDA has reapproved Tysabri for use in multiple sclerosis.
Rick: Well, you described earlier the treatment pyramid, much like the food pyramid, and currently physicians are debating two types of treatment approaches vis-à-vis that pyramid, bottom up or top down. So explain for our listeners, Dr. Melmed, what those approaches mean for patients.
Dr. Melmed: Well, this is a very hot topic for people who treat patients with IBD. What's the best way to approach treatment? As I mentioned before, traditionally we've looked at treatments in the form of a pyramid starting with the safer but perhaps less effective medications at the bottom of the pyramid and then working our way up, waiting for a level of treatment to fail before moving on to the next level of therapy because of potential side effects that may be more significant.
There's a new approach that was advocated by a European study that was just done, and the results were released in the last year were very provocative. What this study did was, instead of having everybody start at the bottom-up approach, starting at the lower levels of therapy, the study took a group of people with Crohn's disease and chose to treat half of the patients in that bottom-up approach but the other half of patients started them on the more aggressive therapy, started them on biologics, first.
Rick: At the top of the pyramid.
Dr. Melmed: At the top of the pyramid, exactly, without going through all the levels beforehand. And then they followed these patients out for two years to see how many times were they hospitalized, how many people ended up with surgery, how many times did people flare, how often were people placed on steroids. And it seemed that the people who were given the more advanced therapy initially at the get-go did a lot better for all of those parameters.
The problem with treating with top-down is that we're exposing everybody to those potential side effects that we discussed earlier. Does everybody need to be treated eventually with a biologic who has Crohn's disease? I don't think so. I don't think anybody would say so. On the other hand, it seems that taking that approach certainly for those people who will end up needing those medications and do have more severe disease, that approach seems to overall do much better for those patients in reducing again complications of surgery, hospitalizations, flares and the need for steroids.
Rick: So do you think that disease severity is the key consideration here?
Dr. Melmed: Well, I think there are a few considerations, and I don't know that top-down therapy is quite ready for prime time approach in everybody. But disease severity may well be one group of patients – i.e., those who have very severe disease at the time of presentation, at the time that they're diagnosed, may be candidates for top-down approach. Hopefully, we'll have a blood test in the future that will be able to tell us if your disease is severe, you're a person who will likely end up on biologic therapies, therefore we should start to treat you sooner with biologic therapies.
Rick: Right. And of course the patient is going to be involved in this decision-making process, right? They're going to say I want that therapy or something different. At what point, Doctor, do you think that a doctor should introduce biologics as a treatment option for a patient, then?
Dr. Melmed: Well, I think that it's really an individual-by-individual approach. It's difficult to say in general terms when a biologic should be introduced. I think most people are practicing using the step-up type of approach with the step-up philosophy because that's the way it's been done. Biologics are relatively recent on the horizon, but I think as people have more and more experience with them and understanding perhaps who will be more likely to benefit from that type of approach, you may be finding that to be more common.
Rick: How about the issue of medication compliance? How important is it for these by biologics to be taken exactly as prescribed? What if you skip a dose?
Dr. Melmed: It's critical that these medications be taken as prescribed. Initially when Remicade first came on the horizon, we were treating patients with a single infusion or a single set of infusions and then stopping the drug. Then later on down the line if somebody needed another infusion, they'd get another infusion.
And we found that that approach seemed to increase the risk of losing efficacy over time and also increasing the risk of reactions to the drugs.
So that's what we've subsequently learned, and now Remicade standardly is given on a regular interval. The standard initial treatment for Remicade after the first three infusion doses is to be given every eight weeks, not to skip a dose. The danger in skipping a dose is that you do risk increasing that risk of the drug not working as well for you as well as the risk of reaction.
Rick: I guess then if you're a patient considering a biologic, you should also consider whether or not you're likely to stick with the program and take your medication as prescribed, right?
Dr. Melmed: Exactly. And I would venture to say that that's not just true for the biologic agents but also for the nonbiologic agents, particularly the immune modulators, because some of those medications do require monitoring with blood tests, etc., which does require adherence to the medication program as well as to being involved with your doctor and having blood tests, as recommended.
Rick: So, Dr. Melmed, how can a patient weigh all these options here and figure out which biologic or nonbiologic therapy is right for them? How should they approach this whole question? And cost, unfortunately, is a factor, is it not?
Dr. Melmed: Yes, cost is a factor.
But with regard to approaching which biologic, I think if a person is up to the point where their disease seems to mandate a biologic or that the discussion with the doctor shows that a biologic might be in their best interest, we right now have only two to choose from, Remicade or Humira [and Tysabri]. The big difference to the patient taking the drug, I think, as far as choosing which of these medications to take is that Remicade is an infusion. That requires a few hours off from school or from work to go to an infusion center, but once you're on a stable dose, it's only once every two months. [Tysabri is also given by IV infusion once every 4 weeks.]
Rick: Right.
Dr. Melmed: On the other hand, Humira is a self injection which you do on your own every two weeks, after being taught of course how to do it. And it gives people more independence, more freedom and control of administering their own medication. On the other hand, not everybody is up to being able to give themselves injections.
Rick: Right.
Dr. Melmed: So when it comes down to choosing between those two, I think that's a big factor as far as lifestyle, which one is the most convenient for my lifestyle.
Indeed these drugs are costly, and we don't like to think of costs factoring into what's in the best medical interest of a given person, but unfortunately that's the world we live in. Someone has to pay for these medications, which are generally covered by insurance companies as long as they are medically justifiable. The one difference is that Remicade does have infusion costs associated with it, whether it's at a doctor's office or in a hospital, as opposed to Humira, which is just the medication cost itself.
Rick: Right. And are there patients out there listening to this who either should not or cannot take biologics?
Dr. Melmed: Yes, there are certain contraindications to biologics. One contraindication might be having an active infection. Another contraindication to starting biologics would be having cancer. And this is a complex issue which requires the input of an oncologist if somebody really would benefit from the biologic and they have the history of cancer or certain kinds of cancer.
Another group of people that we are cautious about are people with heart failure because Remicade or biologics, anti-TNF biologics, can potentially exacerbate heart failure. And that's an important consideration, particularly in older people.
Rick: And once someone goes on a biologic, do we think of it as a life-long treatment, or is there a maximum time?
Dr. Melmed: Well, at this point in 2007, unfortunately we say the disease is a life-long disease, and if the treatment is working, it may be a life-long treatment. And I say "may be" because we don't know what's coming around the corner. Some doctors have the standard line that this is going to be your treatment until there's a cure or until you stop responding to it. I like to have a discussion with my patients every time I see them about the risks and benefits of continuation of therapy.
But usually if somebody has been very sick and the medication makes them better, they will be reluctant to stop that treatment out of the concern that by stopping the treatment, they will allow that disease to make them sick again. And with regards to the biologics there is some concern, as we discussed. As you take a break from the drug, you skip some doses, when that drug is reintroduced, it may not work as well the next time around. And because we're so limited in what our drug options are – again, there are only two approved biologics right now – that's a risk not many patients are willing to take.
Rick: Right. Only so many bullets in that gun; you don't want to waste them.
Dr. Melmed: Exactly.
Rick: We have a lot of e-mail questions coming in, Doctor, so let's get right to them. First one from Hartland, Maine, and this listener writes, "I am now in the process of being qualified for Remicade. I do have concerns about side effects, particularly cancer. My father had cancer and died. My mother has had lymphoma, so I am nervous. Is there any additional risk if cancer is in the family?"
Dr. Melmed: That's a good question, and I'm afraid to say that I don't know the answer to that. I think that we think of cancer in an older person as being sporadic, meaning that it's not genetically inheritable. But some cancers are genetically inheritable, and I think that's a frank discussion to have with your doctor.
Again, the risks and benefits of a treatment are not just what the risks are but what are the risks of not going to that treatment. If this particular individual is out of options for treatment of the Crohn's disease, then this may be his only option, so that needs to be taken into consideration as well.
Rick: Yes, indeed.
E-mail from two residents in California: "Where does Entocort EC (budesonide) fit into the pyramid?" That's the treatment pyramid you described earlier.
Dr. Melmed: Yes. Entocort EC probably fits in between the bottom and the second level of treatment that I described. Entocort is a steroid, but it's a steroid that's been designed not to be absorbed into the bloodstream. It's supposed to act by coating the inside of the gut, particularly the ileum, which is most affected by Crohn's disease, with steroid. It's not a hundred percent true that it doesn't get absorbed, about 10 percent of it does get absorbed, so there is some steroid effect in the body from Entocort, but it does seem to be less than the usual doses of prednisone that are given for treatment of Crohn's disease. So I'd probably put it somewhere in between those bottom two levels.
Rick: Are the side effects typical of a steroid treatment?
Dr. Melmed: They're usually less, again because it's less absorbed.
Rick: Okay.
E-mail from North Eastham, Massachusetts: "How much does stress come into play with Crohn's disease? Does stress actually cause a flare?"
Dr. Melmed: Well, all my patients tell me that it does, so I have to believe them. On the other hand, it's hard to say, when looking at large groups of people in studies that have been done looking at this question, that stress is a specific factor. But certainly people who are in times of stress do report increased symptoms, and whether those symptoms are due to Crohn's disease or perhaps a little diarrhea from nervousness related to other factors that anyone might get is difficult to answer.
But certainly a lot of people do think that stress correlates with their disease, and they may actually be proactive in times of stress about increasing their therapy.
Rick: And, I'm curious: Do biologics affect stress-related Crohn's any differently than other treatments?
Dr. Melmed: I don't know. I don't know that stress-related Crohn's is thought of in a different way in regards to treatment, but I don't know the answer as far as the impact of biologics on those kinds of symptoms.
Rick: Okay.
Jo Ellen in Spartanburg, South Carolina writes, "I take Remicade every seven weeks, also methotrexate. I do very well. Lately I have developed a series of warts running along a line. How does this fit in with immune problems and biologics?"
Is there anything for her to be concerned about there?
Dr. Melmed: Well, I do think that that needs to be brought to the attention of the doctor that's prescribing those medications. Warts are typically due to some virus, and methotrexate and possibly Remicade can impair the body's ability to fight viruses. So I do think that that should be brought to the attention of the doctor that's prescribing those medications to discuss if it makes sense to stop one of those medications or if that's something that can just be continued.
Rick: Right. We have an e-mail from Valdosta, Georgia, and it's something we mentioned earlier, but it bears repeating. "Is it true that once you start a treatment such as Remicade it is a lifetime commitment?"
Dr. Melmed: Well, like we discussed earlier, I think that because this is a lifetime disease we will likely need to treat this with lifetime medication for those people that require medication to get their disease under control – i.e., those people with more significant disease. And I think again with regard to starting Remicade in particular, Remicade works well, and people who need it are people with moderate to severe disease.
The question is: Are you going to want to stop it if this drug seems to work for you and the chance of it continuing to work for you may be diminished if you do end up stopping it in the long-term.
Rick: Which also brings up the question: If you fail one biologic, will you necessarily fail another biologic? Or is it worth trying something else?
Dr. Melmed: That's a very good question. I think it requires careful consideration as to what is the failure of the first biologic. If somebody, for example, has responded well to Remicade but over time has lost their response, usually that is due to that mouse protein that we discussed early on. Their immune system seems to react against the mouse protein. It's not that the drug is less effective. It's that their immune system is taking the drug out of their system, and that's why that Remicade is becoming less effective.
Rick: Yes.
Dr. Melmed: But that's not to say that TNF isn't a mechanism that's driving their illness, and therefore that would be a very good candidate to switch over to Humira, which is another TNF blocker that doesn't have the mouse component. Because again it seems to be that that drug worked, but it's becoming less effective over time. And studies with Humira were actually done in people who lost their response to Remicade and showed that people who lost their response to Remicade did very well when they were treated with Humira.
That's different than somebody who didn't have any response to a TNF drug like Remicade. If there was no response to Remicade we just don't know if those kinds of people will respond to switching over to another TNF blocker. However, once Tysabri becomes available, that's a totally different mechanism.
Rick: Yes.
Dr. Melmed: So if someone didn't respond to a TNF blocker, they may very well respond to Tysabri. And again I don't know that we have specific information with regard to that, but theoretically targeting another pathway would seem to work.
Rick: So there are options if you've done well on one TNF treatment to maybe switch to a different one, maybe one that is yet to be developed.
Dr. Melmed: Exactly.
Rick: That's good to know.
A question from Waco, Texas, Jeffrey writes, "I was told that taking prednisone can affect the accuracy of the TB skin test that is required prior to starting Remicade. Since I had been on prednisone, I had the new TB blood test, which is called the QuantiFERON TB Gold test or QFTG. The health department says it can have false negative results. In that case will a chest x-ray rule out TB?"
What can you tell Jeffrey, Doctor?
Dr. Melmed: There is a new test as Jeffrey's doctor is obviously aware of, this QuantiFERON Gold test, which is a blood test. Now, the QuantiFERON test can also be affected by being on medications that suppress the immune system. It works in a way that's different than the PPD skin test for TB but also can be affected. A chest x-ray is not affected by being on these medications, so if there has been exposure to TB or somebody has a history of TB, then a chest x-ray should be done.
On the other hand if somebody doesn't have any history of exposure to TB, it's a discussion with their doctor about the most appropriate way to feel comfortable that TB is not a concern.
Rick: And is someone disqualified or discouraged from going on, say, Remicade if they've just been exposed to TB, or do they have to have an active infection going on?
Dr. Melmed: If somebody has a positive TB test, then I will typically involve an infectious disease specialist to begin treatment for latent TB. And once that treatment has begun and usually after a period of about a month or so, at that point Remicade can safely be initiated.
Rick: I see. Okay.
E-mail from Franklin, Kentucky. This person says, although they're writing from Kentucky, "I live in Australia and had been suffering Crohn's with three resections along the years. I do not take any of the drugs now, but I'm still suffering chronic diarrhea. Can this form," I think they're referring to biologic treatment, "help me?"
Dr. Melmed: I don't know that there are studies that show that biologic treatment is effective in the prevention of Crohn's disease in people who have had surgery. It would make sense that they are effective, but that hasn't been specifically studied. I think that's a very important consideration, though, after surgery – especially in somebody who has had three surgeries, because as we know in Crohn's disease surgery begets more surgery, and that medication should be considered if these symptoms are suggestive of ongoing inflammation.
Rick: Just strikes me that you'd want to do anything you could to reduce that inflammation, and wouldn't biologics be an option there?
Dr. Melmed: Yes, indeed they may be.
Rick: May be. So talk with your doctor.
Dr. Melmed: Exactly.
Rick: E-mail from Alcoa, Tennessee about weight gain. This person says, "I was diagnosed with Crohn's and every doctor I've talked to, every report I've read, it says that Crohn's will make you lose weight. But I am gaining weight and retaining water throughout my body. What's going on?"
Dr. Melmed: Well, this sound like a very individual question.
Rick: You can't diagnose.
Dr. Melmed: Well no, it's a circumstance which may again require a discussion with your doctor. Crohn's disease does typically affect the weight in a way that causes people to lose weight. If someone is gaining weight or retaining water, there may be other things going on that require investigation.
Rick: Do you see that frequently with your patients?
Dr. Melmed: Weight gain?
Rick: Yes.
Dr. Melmed: No. What I'll find is in somebody who's lost at lot of weight, and then we start therapy they'll regain that weight that they lost. Being on steroids may also cause people to gain weight because it really drives one's appetite up. But if one is starting to retain water and they're not on steroids and they haven't lost a lot of weight, I think that requires further evaluation.
Rick: Okay.
E-mail from Raleigh, North Carolina: "Is it possible to have both ulcerative colitis and Crohn's disease?"
Dr. Melmed: We haven't really discussed ulcerative colitis, but ulcerative colitis is sort of at the other end of the spectrum in the group of diseases called inflammatory bowel diseases, which are essentially these two illnesses, Crohn's and ulcerative colitis. The primary difference between the two is that ulcerative colitis only involves the colon. Crohn's disease can involve the colon as well as other parts of the gut. So sometimes it can be very difficult to distinguish between the two when an individual has inflammation located only in the colon. It's often not that important to make that distinction because much of the therapy overlaps between the two diseases.
Rick: I see.
Dr. Melmed: But in the more advanced, more severe disease, it does become important, and it's not really possible to have both diagnoses, but there may be difficulty distinguishing between the two.
Rick: Okay.
We got an e-mail from Doris in Kingston, Tennessee who says, "I'm a single mother who's finding it hard to manage with very little income and twins to support. I have no doctor, no medical insurance." Although she says, "I have no meds," I'm not sure what that means. No medical insurance we'll assume. "Where can I find help?"
And I'm going to actually field that question because we've done a program here at HealthTalk and our guest was someone named Jennifer Jaff, and she has a wonderful Web site designed for just such people, Doris. So go to this Web site: www.advocacyforpatients.org. And she deals a lot with people in your situation, so I'm sure she can provide some help for you there.
Another question comes from Hollywood, California. "My child is about to start Humira. What truly are the risks?" Doesn't say how old the child is. "What do you do when they get an infection such as a cold or the flu? I have read that an infection could be fatal. Do you have any statistics?"
So a concern here about the risks of starting a child on Humira, Doctor.
Dr. Melmed: Well, right now Humira is in clinical investigation for the pediatric population, so I would imagine this child is under the care of a doctor and a whole clinical trial team that would very much want to know if there's any infection or any suggestion of infection involved.
From what we know about Remicade in children, which is approved, the side effects in children don't seem to be too different, to my understanding, than in adults. But infections do need to be taken seriously, and in general I encourage my patients to let me know if they have infections of any kind and to be proactive about treating them if they require treatment.
Rick: Do you have to stop your biologic treatment if you do get an infection, say the flu?
Dr. Melmed: Not necessarily. I think again it's an individual case-by-case basis, but if somebody is sick, I will have them delay their next infusion.
Rick: Okay. E-mail from, looks like, Oregon, yes: "I take Remicade every six weeks and methotrexate injections weekly. Can you explain why some who take Remicade do not take methotrexate and why others do, because I hate the side effects of methotrexate, and I'd like to stop taking it."
Dr. Melmed: This question brings up another very hot topic right now in the treatment of people with Crohn's disease, and that is whether or not people on biologics should be on additional medications to help prolong the effectiveness of those biologic agents. So for example being on methotrexate reduces theoretically your body's immune response to Remicade and may make Remicade last longer in you.
Rick: Interesting.
Dr. Melmed: Another reason to be on methotrexate might be to treat additionally over and above the treatment for Remicade. So without knowing the individual's circumstances, I'm not sure why this individual is on both medications, but there certainly is rationale and justification.
On the other hand, the risks are potentially augmented when you're on two medications that suppress the immune system, which is why this is a very hot topic now among people who treat Crohn's disease. And therefore I think this requires a detailed discussion with the doctor about the risks and benefits of being on both medications.
Rick: Yes, indeed.
E-mail from Farmington, Minnesota, "I am on Humira that since July, and my blood pressure has gone up. Have others experienced the same thing? Also my eyes have been redder than usual. Is this something I should be concerned about long term?"
Dr. Melmed: Both of these are uncommon side effects. Any potential side effect could be related to any drug. I think these again should be brought up with this individual's doctor. The high blood pressure, I don't know if there's a background of high blood pressure in this individual or other medications that may be contributing, such as steroids. And redness of the eyes may be manifestations of inflammation, and whether that's an indication of active disease is also something to consider. So again this is something to be brought to the attention of the individual's doctor.
Rick: Right.
E-mail from Rockland, Maine: "I have found that by switching from regular skim milk to soy milk and Lactaid and by eating a gluten-free diet, my condition has been helped somewhat. Is there any other dietary change I should consider?"
And I know that you get a lot of questions about diet. What do you tell your patients, Doctor?
Dr. Melmed: Yes, a lot of people ask about diet. Diet is something we have control over, and I think that for that reason alone we'd like to think we are doing something or can do something to impact our disease. I'm not sure that there is much evidence in the way of showing that any specific diet can impact the course of the disease. On the other hand, I think that if an individual has noted that certain foods make them feel better or make them feel worse, for that individual, those foods should be avoided or sought after.
In general somebody with diarrhea, for example, may feel better by avoiding dairy products because anybody with diarrhea could have worse diarrhea with dairy products. The mechanism of absorbing dairy is impaired in people who have diarrhea and it can make it worse. There can be food allergies to soy or to wheat that may not be apparent in somebody who is healthy, but once they get sick with Crohn's disease, it can be contribution of some food allergies related to those substances.
So I think it's a highly individual question. But as a general philosophy, I don't particularly advocate the avoidance of any specific foods with one exception and that being high fiber in times of active disease. Theoretically speaking, fiber, which stays in the gut and doesn't get absorbed, could potentially be irritating to areas that are actively inflamed. And this is all theoretical.
Rick: Okay. And with that I'm afraid we're just about out of time. But before we go, I'd like to get some final words from you, Dr. Melmed. Now if they're thinking about biologics, what are the three most important questions a person with Crohn's should ask his or her doctor when considering biologic treatments?
Dr. Melmed: Well, Rick, I think your audience probably doesn't need my advice because they're doing the most important thing that I think anybody should do when considering treatment, which is to be educated. And if I had to say what three things to bring up with your doctor when considering these medications, make sure to ask: "What are the risks?" Make sure to ask, "What are the benefits?" and understand how those may contrast with each other. And I think the third most important thing to discuss with your doctor is, "What are the alternatives?" Are there other avenues of approach to treating this disease that makes sense in the context of your particular illness and how it's affecting you in your life?
Rick: Great. Dr. Gil Melmed, thank you very much for joining us today.
Dr. Melmed: Thank you, Rick. My pleasure.
Rick: Thank you in the audience.
From HealthTalk, I'm Rick Turner.

subset: commoncrawl


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Applying to the George J. Mitchell Scholarship Program
Thank you for your interest in applying to the George J. Mitchell Scholarship Program.
The George J. Mitchell Scholarship Program is a nationally competitive award for U.S. citizens sponsored by the US-Ireland Alliance. Named in honor of the former U.S. Senator's pivotal contribution to the Northern Ireland peace process, the Mitchell Scholarship is designed to introduce and connect future American leaders to the island of Ireland, while recognizing and fostering academic excellence, leadership, and a commitment to public service.
The application cycle for study during the 2018-19 academic year (Mitchell Class of 2019) has begun.
Key Dates
Mitchell Scholarship Program Class of 2019 Application now open!
Mitchell Scholarship Program Class of 2019 Application Deadline (for study in Ireland during the 2018-19 academic year): September 29, 2017 5:00pm Eastern Time
Semi-Finalist Skype Interviews: Week of October 23, 2017
Finalist Weekend: November 17 & 18, 2017
Mitchell Scholarship Program Selection Announcement: November 29, 2017


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There are many states in the country with high crime rates. Not surprisingly, these states are often the ones that send the most people to prison. Other common denominators among states with high incarceration rates include a population with less education and in high levels of poverty. Yet, these factors do not fully explain Texas' high rate of incarceration.
A recent report released lists the states that send the most citizens to prison. Number three on that list is Texas. Yet Texas is also one of the safest states in the country. According to some experts, in some instances states with high rates of imprisonment per capita prison have made a political decision in favor of incarceration. Certain policy choices, including minimum sentencing requirements, three-strike laws and tough approaches to certain crimes, including those related to drugs, can result in higher incarceration rates.
While many states in the Northeast portion of the country have started to loosen up on their drug laws, for example, Texas and other states high on the incarceration list have maintained strict policies of tough sentencing for drug charges.
Being charged with any crime is a serious matter and drug charges are no exception. A drug-related charge in Texas can carry heavy consequences. If convicted, an individual could experience substantial prison time, fines and damage to reputation.
This is why it is so important to obtain vigorous representation when charged with a drug crime. An experienced criminal defense attorney will point out weaknesses in the prosecution's case and assert relevant defenses. Given the high stakes and state focus on such charges, skilled representation could be the difference between a criminal conviction and an acquittal or dismissal of charges.
Source: Huffington Post, "States Sending The Most People to Prison: 24/7 Wall St.," Michael B. Sauter, Samual Wlgley, Alexander E.M. Hess, July 28, 2013.


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I just LOVE this "Snow Friends" (K92) stamp from Great Impressions Rubber Stamps. By far currently one of my favorite stamps, granted I love snowmen!!
I love how this card turned out. Love the fun colors I used!!
Have a great Wednesday!!
Welcome to my blog! A place for me to share my love for creating cards, scrapbook pages and more! Enjoy your visit! Thanks for stopping by!
I have to agree with you. This turned out fantastic. Those snowmen are adorable.
Thanks for sharing
Love the sweet colors and the cute image! Merry Christmas!
Oh this is so cute...I love this snowman stamp..TFS


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This years Celebrity Dinner promises to be another exciting event!
This years Celebrity Dinner will take place on Sunday, July 10 at the Royal Canadian Legion in Summerside. Organizers are pleased to have Bell Aliant returning as the title partner for the Celebrity Dinner event.
Organizers are also partnering with the Summerside Boys & Girls Club for this year's Celebrity Dinner, and together are excited to be hosting this community event.
Mr. Paul H. Schurman will emcee the evening's program.


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MUSIC: East Meets West – Vajra Album Review 'Pleroma'
Composer and keyboardist Annamaria Pinna's "self-imposed exile" in India (touted widely by music bloggers catching on to her dark, melodic sound as Vajra's lead singer) was time well spent. Attaching shape and color to sound as someone living with synesthesia, Pinna began playing violin at six, flute at nine and later studied music theory at Juilliard. The daughter of a former monk and school teacher, Pinna created the alt-prog rock ensemble while abroad, intertwining East Indian themes and influences with experimental elements during her stay in India. Stylistically, Vajra distinguished itself with the 10-track début album, Pleroma, released last year on the summer solstice (June 21). Since then, interest has grown as Vajra tours and explores an enlightened realm of music evident in the group's emotive rawness, ingenuity and fearlessness.
In March, Vajra joins the lineup for Heart of Texas Rockfest in Austin, and the group continues to sell out shows, impressing crowds throughout NYC to the West Coast. Pinna's deeply moving presence in the studio and on the road sets this underground enchantress apart from the rest. She says there is divinity in creativity, noting the new album is an exploration in paradox. I'm compelled to agree. Vajra's music intoxicates at times, apparent on Intuition and Erode the Will; yet remains hauntingly nuanced and charged at others (listen closely to Blind). The amped music video, Inside the Flame, has quickly become a fan favorite on YouTube, with it also featured on the Gothic Magazine Music Compilation Part LVI.
The debut LP, written, arranged and produced by Pinna, features some industry heavy hitters. Tom Baker (NIN, Foo Fighters, Ministry, Prince) mastered Pleroma, with Blake Fleming (formerly of The Mars Volta) on drums, ex-Harley's War guitarist Will Dahl, Dirty Pearls bassist Doug Wright and Turtle Jon on Tabla. Grammy-winner Sylvia Massy (Tool, System of A Down, Prince, Johnny Cash) mixed the album and co-produced vocals.
In its entirety, Pleroma leans heavily on the deft arrangement of searing synths, powerful tribal percussion and intricate guitar play accentuating Pinna's vocals awash in hypnotic mysticism and cosmology. Catch Vajra live, if you can. Or better yet, get this album and don't waste any time fully experiencing the divine aural discoveries on Pleroma.
Vajra: http://www.thevajratemple.com/
Vajra on Bandcamp: http://vajratemple.bandcamp.com/
Vajra's YouTube channel: http://www.youtube.com/vajratemple


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Join us for the MOTOTRBO™ launch webinar on 10th September to hear all about the newest additions to the MOTOTRBO family – the DP1000 Series, DM1000 Series, DM2000 Series & DP3441 Radios.
These new radios allow more users to experience the benefits of MOTOTRBO digital – that's Digital Remastered. They provide increased choice by offering a greater range of models to meet a wider range of requirements & price points.
Click here to Register
Date: Tuesday 10th September
Time: 10:00 - 11:00 BST
The webinar will show the features & benefits of the new radios, explain how they fit into the MOTOTRBO portfolio & provide a chance to ask questions.
© Copyright RadioTrade 2020 | Legal | Sitemap |


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Farm-to-Flask isn't a slogan, it's our operating principle.
At Maine Craft Distilling, we have an inherent understanding of what we stand for and what we stand on. We're respectful and appreciative of the environment around us and the beauty that can be created from it. We make thoughtful decisions, care where the things in our life come from, and gain a sense of presence from it all.
This is why we create all our products in small batches using carefully designed methods and artisinal practices. Because we believe spirits can be made in closer harmony with their local surroundings.
That's why every bottle and can blends the land and pride of Maine with our down-to-earth, can-do approach to life and liquor. So for those who care about craft and the story behind it....
Farm-to-Flask is not a slogan at Maine Craft Distilling; It's our Operating Principle.
Brands: Fifty Stone, Blueshine, Alchemy, Sprigge, Ration, Tashtego, Queequeg, Black Cap, Chesuncook, Whipple Tree, Blueshine Lemonade, Cranberry Island Cocktail, Maine Mule, Black Cap Vodka Soda, G&T
We tie the origins of gins past with our spirits of today by using the old English spelling of the word Sprigge. A sprigge of juniper and its berries has long been held in high regard. It is from this that gin was born.
Inspired by the rolling stone walls covered in juniper which define the fields and farms of Maine, we have created a hearty and full flavored gin that places the noble juniper front and center and then let it rest in oak barrels. We invite you to enjoy a fresh, bold take on a time honored favorite.


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100x76 pixels. That's the size of a ZBC thumbnail, and is all most people need to be able to spot a new image by boozy floozie. Their unique style makes Mark Bannerman one of the most recognizeable artists at ZBrushCentral. Over the years he has also contributed more than 100 images, making "The Flooze" one of ZBC's most prolific artists!
We finally managed to catch up with Mark recently and pin him down long enough to do an interview. Read on and you'll soon see that he's every bit as colorful (and eccentric) as his art!
Hi Mark. I'd like to begin by learning a bit more about you. Could you provide some insights into the artist behind the art? According to your website bio, you spent some years as a child in Singapore. What was that like?
Hot, very hot, I spent the first few years sleeping under my bed not on it and running around naked all day. In that respect not much has changed. My favorite pastime was playing in monsoon drains and biting the heads off cockroaches, which I'm pleased to say that I have stopped. As a child you take your environment for granted but it was only when we moved back to Britain that it felt like I stepped out of a Technicolor world into a black and white movie. If I think of Singapore I think of colors to this day.
What led you to become a digital artist, as opposed to using more "traditional" media?
My initial eureka/"Ooh, I like that!" moment was in the 1970's when I saw an animation by the artist Ed Emshwiller called "Sunstone" using video and 3D graphics technology. It was this more than anything that stood out in my imagination from the work pioneered at that time simply because Emshwiller had harnessed the technology to create art of a transcendental nature that was digital but also emmotive. About this time I also found a book on digital art that showed the work being done by Sun Microsystems and pioneers such as Ed Catmull. As a kid I loved both art and science. When home computers dropped to a sensible price with the processing power to create art with an adequate degree of fluidity and responsiveness, I jumped in with great excitement. The switch over was gradual because it takes time to adjust with a comparative sensitivity from traditional media to digital methods. Initially it felt like all my time was spent learning but not really doing. The first hurdle to overcome is being in awe with the myriad of visual possibilities available to digital artists as well as the vast toolsets of the applications. I remember it took me few days to get over the fact that my working file was in a digital folder and not stored in a plan-chest. I still mentally imagine I'm mixing real paint, painting on an imagined surface and playing with clay when I work digitally - I find it helps me feel connected with what I'm working on.
Bryce was my first taste of 3D and I still have an enormous affection for it; so much so that I always update it even though I no longer use it. Playing with Bryce began my fascination and excitement with working in 3D but it took some years and experiences with disappointing software that promised more than it delivered to finally get into 3D.
Your style is completely unique. How did it come about?
The style is a linear continuation of the way I approached painting before I created digital 3D pieces. ZBrush was the first 3D application that reconnected me to how I worked as a painter. It helped me bring a more relaxed human element back into my 3D work. i.e., choosing to include the imperfections evident in my originating sketches by using it's responsive sculpting tools.
What advice might you give to other artists seeking to find their niche?
I would say don't be frightened of making mistakes, keep playing and don't measure yourself by the great work that others may be doing. Be patient and allow yourself time to develop and find your own flow. When we talk about a visual niche as a manifestation of personal expression I think it vital that our drawings/sketches should inform this work - it's our drawing like our voices that give expression to our thoughts. Time spent away from the computer developing your compositional skills, traditional skills, tapping into your imagination, visiting galleries etc. is just as important as the time spent at the computer perhaps more so.
On a practical basis a good habit is keeping notes of how you achieved certain effects or approaches when experimenting or creating your pieces. Also try random experiments and freeform work such as falling onto the keyboard and mouse to see what happens.
On a broader perspective I think it helps to have lived some life, fallen in love, experienced tragedies etc. because it's all these other indefinable things together with the technology that make us communicators of shared experiences.
How did you discover ZBrush?
I read about the very first release in Computer Arts magazine. I can't remember how they actually described it but they certainly earmarked it as intriguing. Somewhat eccentric perhaps, but definitely a new and wholly individual approach to 3D. The whole concept pressed all the right buttons in my mind, particularly with the marriage of 2D and 3D together as it seemed to be the fulfillment of what I dreamt might be possible with 3D.
Those were the early days when it was a regular occurrence for the occasional clown to stagger onto the ZBrush forums deriding ZBrush as some cruel aberration sent to torment their minds.
How do you use ZBrush in the creation of your illustrations? (Details, man. Details!)
Where to start? I use it for almost everything from painted backdrops, texture and UV creation, sculpting, mesh creation, collage techniques, post production. I try and break down a piece early on to see whether 100% ZBrush will give the best expression to the essence of the piece or if the components should be staged within another application and which bits should be done where etc. etc. At all times I'm always looking for the most fluid approach to creating the finished result because I find the best work comes when you have momentum/flow. A typical example of what I mean would be... let's say I need some displacements on a form/object. Well if I know my construction environment is ZBrush then I would get the displacements roughly in the ball park for the effect I'm after and instead add some of the finer details in post production using the bump brushes. This saves time because you're placing the effect in context with the overall image and not just the object in isolation - the eye is more impressionistic/ selective of how detail is perceived than a camera.
When creating work totally in ZBrush I find it good policy to keep in mind how many layers you may need to use, what will be on what layer and why, as well as what layers should be baked to enrich the sense of lighting and tonality in your work . I prefer this approach to multi-pass render techniques favored by others.
One of the absolute joys about working in ZBrush using layers is the freedom when texturing the objects on the canvas, free of the complications common with standard 3D texturing methods. I find when working with ZBrush in this way that it captures the excitement I feel with traditional painting techniques, i.e. committing oneself to certain approaches and fast decisions. I tend not to be as prudent with saving versions as I should be because I enjoy the sense of risk I experienced when creating with traditional media. Working in other 3D applications can be a much more clinical affair.
Unfortunately I've never found a magic formula. Every piece seems to raise different technical issues and approaches to the pieces that have come before. This is where 3D for me fractures from how I worked as painter in it's complexity. I think at the end of the day it's how you approach what you do and all about breaking the project down into definable chunks. I use daytime for the logical bits, afternoons to eat biscuits and nighttime for the more emotive touches. But again, I would say that achieving a degree of creative freedom within ZBrush is all about flow, finding personal habits, making fast considered choices and spending a lot of time learning its vast toolset with which I regularly suffer amnesia.
What percentage of a typical illustration is done using ZBrush?
A difficult question in the sense that I will sometimes choose a 100% ZBrush construction and rendering environment - but to generalize, a consistently high percentage of all elements have passed though ZBrush. Even when I haven't created a mesh in ZBrush, or if I choose another application for scene construction I regularly like to bring it back into ZBrush to add those little indefinable touches and human imperfections that bring the mesh closer in line to how I have drawn the form in my working sketch. This has become a habit for me and a pleasure - I'll regularly find myself in ZBrush whether it's absolutely required or not. It's my little home so to speak.
Is there a particular feature that really stands out for you? In what way?
If I had to pick one of the myriad of gems to be my Bride I'd have to say Projection Master, simply because every time I use it I laugh. Anyone who's sweated over creating UV's for organic forms can't help but cackle at what a joy it is to rid yourself of time consuming UV creation and get straight down to texture painting. To have at your finger tips so many brushes, ways of applying the brushes, textures and alphas is a delight - I just couldn't praise it highly enough nor bless it enough when I think of the hours saved that I can spend away from the computer.
Out of all your illustrations, do you have a favorite? What is the story behind that one?
I think it would be "Mrs McMurdo's Perspective Correctional School for Wayward Gals". I choose this because it was the first completed piece where I knuckled down to make ZBrush work for me with regard to achieving a rich environment, a playfulness and atmosphere in my 3D work that connected with my painting work.
What would you say to other illustrators who are thinking about trying ZBrush?
That you've nothing to lose but your sanity. I think for any artist who wishes to explore 3D it's a must-have tool. That said, I think to achieve any degree of fluidity in 3D you have to have a certain kind of brain. I've certainly watched many illustrator friends weep and tear their hair out with 3D only to give up. At the end of the day an artist must choose a medium that allows them to feel free and flow. If the techniques or surface get in the way of communication then the work fails.
Okay, I just have to ask. Where did "boozy floozie" come from?
Boozy floozie is an expression of my gregarious feminine gin tippling side/alter ego. I am ashamed to admit that I was rather daunted by joining a 3D forum. At that time most 3D forums were occupied by somewhat aggressive men who had spent a king's ransom on their software, and who seemed to reply to most newcomers (with perfectly reasonable questions) with "RTFM" . I suspect they were angry because they'd spent so much money on their software and were embittered by the long nights of steep learning curves. I noticed that they were, however most gentile and helpful to women and so it was after a glass or two of wine that I nervously joined my first forum ever: ZBC. The evidence of the wine is still there in the misspelling of my name. I had to endure an undercurrent of flirtations, but the gentlemen were most kind. As it transpired ZBC was unlike any other forum in it's cordiality, helpfulness and openness. Becalmed and fully relaxed, I exposed myself (metaphorically speaking) as a man - which my wife assures me I am.
Anything else you'd like to say? This is your chance to talk about anything at all.
Mark's Tips
Below are my Seven Golden Tips for 3D:
Blessed Be The Peacemakers
- Switch off your computer and start drawing.
- Maintain a healthy disregard for the technology and just enough ignorance to make you take risks.
- Get somebody else to do it for you, preferably somebody with no social skills but oodles of talent.
- Don't start in the first place.
- Prepare to spend a lot of time online speaking to other geeks as none of your friends or family will have a clue what you talking about, nor care.
- Good work is created on expensive software.
- Bad work is created on expensive software.
One of the lovely things about ZBrush's continued success is how it has become a common link amongst so many 3D users of different 3D applications, all sharing their insights with ZBrush as well as broader 3D techniques.
A Beautiful World
Whilst on the broader topic of 3D this leads me on to another favorite topic of mine within 3D: Why are there so many men compared to women involved in 3D? I can't think of any other artistic endeavor where the percentage split is so apparent. For the answer to this I turned to my wife who claimed that only men were socially autistic enough to lock themselves in a darkened room for hours with manuals thicker than their thighs when they could be out talking to real people. "How dare she!" thought I, but she does have a point -- albeit a sweeping one. My hope for the future is more women than at present get involved in 3D and bring to the melting pot their insights with 3D. Can you imagine a beautiful ZBrush forum full of gentle flirtations and no geekery - it all sounds very exotic.
Many thanks,
We hope that everyone has enjoyed this visit with a ZBC icon. Thank you, Mark, for sharing!
For anyone who's curious to see the threads from all the images that Mark has shared over the years, click here. Enjoy!
Be sure to also check out our past interviews, which can be found in the ZBrush Artist Interviews forum.


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Bolster pet beds are designed for extra support. The bolster is usually a separated part from the bottom pillow and base of the bed. It is made out of a firm foam so it can support the dog's weight against it.
Dogs that tend to lean when they sleep will love this style. Many bolster beds look like a little couch. Many dogs like to lean their heads over the cushion bolster as pillow support.
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Final Grades – Fall Semester
Final grades will be posted on WebAdvisor on Friday, December 21st (through out the day as they are processed).
Please note that once a grade has been processed in the Office of Registrarial Services that course will no longer display on your "Class Schedule" or on your "Register and Drop Sections" screen on WebAdvisor. This may happen before grades are released.


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Barnes Group Inc. (NYSE:B) today announced that Hans-Peter Männer has been elected to the Company's Board of Directors, effective immediately.
Hans-Peter Männer is the former Chief Executive Officer of Otto Männer GmbH, a leader in the development and manufacture of high precision molds, valve gate hot runner systems, and micro-injection molding systems. Prior to joining Männer in 1990, Hans-Peter studied product engineering at the University of Applied Sciences, graduating as a civil engineer and completed three years vocational training as a toolmaker. Additionally, Mr. Männer served for 18 years as a member of the board of directors of Volksbank Freiburg, a German bank, and for 10 years as a member of the advisory board of WVIB Wirtschaftsverband, a German trade association with more than 1,000 member companies covering a workforce of more than 180,000.
Hans-Peter is currently the Managing Director of Proventus Verwaltungs-GmbH, a limited partnership managing properties and capital assets. He holds an Executive MBA from Steinbeis University, Berlin.
"We are extremely pleased to welcome Hans-Peter to our Board," said Thomas O. Barnes, Chairman of the Board, Barnes Group Inc. "Hans-Peter's extensive experience in the plastic injection molding industry and industrial manufacturing will be a significant asset to the Board. Hans-Peter will help to lead the strategic direction and investment decisions for our evolving portfolio of differentiated technologies and we look forward to his valuable contributions as a Director."
Founded in 1857, Barnes Group Inc. (NYSE:B) is an international industrial and aerospace manufacturer and service provider, serving a wide range of end markets and customers. The highly engineered products, differentiated industrial technologies, and innovative solutions delivered by Barnes Group are used in far-reaching applications that provide transportation, manufacturing, healthcare products, and technology to the world. Barnes Group's skilled and dedicated employees around the globe are committed to achieving consistent and sustainable profitable growth. For more information, visit www.BGInc.com.


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Priya's pool is in serious need of a cleaning. When Keiran shows up to do the job, she is unsatisfied with his work ethic. But as soon as the job starts getting wet, she ends up liking his performance. Collapse
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Results 1 to 4 of 4
Thread: Getting mouse coordinates
- 07-20-2009, 06:57 PM #1Member
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Getting mouse coordinates
I am writing a program wherein I need the coordinates of mouse pointer relative to screen. Using getX() and getY() method we get the x and y coordinates but that is relative to the current frame and to the screen. Is there any other method that returns the coordinates relative to screen? Plz help me
Which GUI library are you using?
- 07-20-2009, 07:56 PM #3Member
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I am using java swing for creating gui.
If Swing, are you getting the x and y with a MouseListener or MouseMotionListener? Or with the Toolkit class? If the first two, then the MouseEvent object passed can get you the Point on screen via the getLocationOnScreen() method. Toolkit's MouseInfo object gets location information that is relative to the screen coordinates.
Similar Threads
Resizing Coordinates In AppletsBy lolmasterzz in forum Java AppletsReplies: 4Last Post: 07-12-2009, 05:17 AM
button coordinatesBy jacline in forum AWT / SwingReplies: 2Last Post: 04-05-2009, 11:58 PM
Java3D: Clicking and getting coordinates?By seabhcan in forum Advanced JavaReplies: 0Last Post: 01-11-2008, 03:46 PM
Object locations via grid coordinates HELP.By deadman_uk in forum New To JavaReplies: 4Last Post: 11-18-2007, 09:32 PM
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Haven't found anything yet?
Non-woven wallpaper collection "Suprofil Style" by Marburg
The collection Suprofil Style combines high-quality creative patterns with fancy, strong plain wallpapers. Timeless designs, stylized graphics and nature motifs in many colours can be combined perfectly with the warm shades of cream, beige and brown tones, but can also be combined with the more powerful plain wallpapers to set strong accents.


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Just last week Yahoo snapped up the 6-year-old, 100 million user platform Tumblr for just over $1 billion. This was not overly surprising, considering the fact that one of Yahoo's biggest needs is some kind of social networking component, which they have failed to create naturally in the past. What makes this purchase particularly interesting is the age demographic of Tumblr, which is very young according to Quantcast; 21% under 18, 30% 18 to 24, and 22% 25 to 34.
This demographic could be a huge boost to Yahoo because of their stodgy image to many young consumers who do not remember Yahoo as an early innovator. The flip side of that upside is that they Yahoo may alienate some of the users because of the perceived image of the company taking over many people's favorite social platform who are afraid it will be altered for the worse (particularly with ads). While it does not look like much will change in the short term, as Tumblr CEO David Karp said they will be operate as a separate business so as, "not to screw it up."
This was a large move for Yahoo, but it appears they aren't done shopping yet, as they have been rumored to have bid between $600 and $800 million on the popular video-streaming service Hulu as well. An integration of Hulu and Tumblr as a commenting and sharing platform attached to Hulu could boost viewers and subscriptions on the heavily advertising reliant video service. Or, it could just be Yahoo spreading its net as wide as possible for the future.
In the midst of all the bidding, Yahoo also found time to re-launch Flickr, with a very snazzy new Web and mobile interface, as well as some fairly drastic changes to its model (especially for Pro users). But, what they thought would appeal to new users, mainly its design that closely resembles that of Instagram and Pinterest, also is annoying its existing core users. This change could create revitalization, or a complete collapse of the platform.
Yahoo's CEO Marissa Mayer appears to not believe Yahoo can build its way into social, and instead wants to buy its way in. SiliconAngle is reporting that Yahoo is rumored to be bidding on two more companies (both between $150 and $200 million) in the social and mobile space.
Can Yahoo force its way in with a cash infusion, or will they ruin hot sites like Tumblr in their quest to become a social networking giant?


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Draft Climate Change Policy to go on public exhibitionIn an effort to address the changing climate affecting the Cessnock Local Government Area, Council has developed a draft Climate Change Policy. The community are encouraged to provide feedback on the Policy during the public exhibition period. The draft Climate Change Policy will be on public exhibition from the 26 February until the 25 March 2020.Read More
What's On
Traffic Management
Cessnock LGA Traffic and Transport Strategy
Managing Traffic in Cessnock LGA
Traffic is managed by two road authorities according to the classification of those roads. RMS is responsible for traffic related matters and traffic facilities on State Roads, while Council is responsible for traffic related matters on Regional and Local Roads within the LGA. State and Regional Roads in Cessnock LGA are highlighted on the map below.
State and Regional Roads in Cessnock LGA
Road responsibilities & classifications
There are three main types of roads within the Cessnock Local Government Area:
- State Road (Road and Maritime Services is the responsible authority for these roads);
- Regional Roads (Council is the road authority, however RMS consent is required for various activities); and
- Local Roads (Council is the road authority and performs functions under delegation from RMS).
State Roads
Matters on State Roads, including traffic management, parking, traffic lights and speed limits, are the responsibility of RMS. To report a problem or make an enquiry on any of these matters, please contact:
- RMS at Roads and Maritime Services ,
- Roads and Maritime Services, Hunter Region Office, Locked Bag 30 Newcastle NSW 2300, or
- Telephone 13 22 13.
Regional and Local Roads
Council is responsible for managing traffic on Regional and Local Roads. To make Cessnock roads safer, Council undertakes a number of tasks such as:
- Investigate traffic problems
- Develop traffic management options to improve traffic conditions for all road users
- Review on-street parking arrangements
- Run Road Safety education programs
- Investigate new street lighting proposal
Speed Limits
RMS set speed limits on all public roads in New South Wales. Centre for Road Safety - Safe Speed Limits
RMS also maintain and erect existing speed limit signs and speed limit numerals marked on the road surface. To enquire or comment on speed limits, please contact:
- RMS at Safer Roads NSW and click on the "Speed Limits" tab,
- Roads and Maritime Services ,
- Roads and Maritime Services, Hunter Region Office, Locked Bag 30, Newcastle NSW 2300, or
- Telephone 13 22 13.
The appropriate agency for enforcement of speed limits and to proactively deal with complaints of speeding motor vehicles and other dangerous driver behaviour is the NSW Police Force. We share your concerns about dangerous driving and encourage prompt reporting of instances of this behaviour to:
- NSW Police Force: 000 for dangerous incidents occurring at the time, or
- Police Assistance Line: 131 444.
NSW Police advise that phoning the Police Assistance Line (131 444), rather than a local police station, frees up Police Officers who could otherwise be on the street actively preventing and investigating crime in the community.
Burnouts, fishtails and donuts are hooning. When a car is driven in a manner that causes the drive wheels to undergo a sustained loss of traction with the roadway, or causes the vehicle to "fishtail" along the road or perform "donuts", the manner of driving is referred to as "hooning".
In the case of this antisocial and irresponsible manner of driving, which is usually accomplished by means of harsh or inappropriate acceleration, combined with severe steering technique. Some offenders even go as far as depositing liquid or other matter on the roadway to facilitate a loss of traction.
Hooning and street racing are particularly dangerous practices, with potential risks of death or injury to the vehicle occupants, other road users and property
From an environmental perspective hooning often produces unnecessary noise and smoke, as well as defacing road surfaces, all of which damages the amenity of the area.
The appropriate agency to deal with hooning is the NSW Police Force.
Police are vested with the power to stop offending vehicles, interview vehicle owners/drivers and take appropriate legal action. Police officers have the training and equipment needed to adequately address driver behaviour issues and they are able to seize and impound offending motor vehicles and remove number plates.
Unfortunately the resources do not exist to have a police vehicle on all streets at all times. Police rely on receiving information from the public to enable them to address dangerous and antisocial driving practices to make our streets safer.
In order to pursue these matters police do not have to witness these offences themselves, they are able to act on witness accounts. When you observe such driver behaviour, simply obtain as much descriptive detail as you safely can about the offending vehicle and contact police.
Traffic Signals
Traffic signals on all roads come under the direct care and control of RMS. For information on traffic signals, or to report a problem with traffic signals, please contact:
- Roads and Maritime Services (RMS) - Telephone 13 22 13.
Street Lighting
Council considers requests relating to street lighting where the lighting effects traffic safety. For enquiries regarding maintenance of existing street lighting, or to report a street light not working, please contact:
- Ausgrid Street Lighting Faults in NSW on 1800 044 808,
- Report online at: Ausgrid .
Parking Restrictions
Council manages parking restrictions on Regional and Local Roads. Local parking restrictions are designed to encourage:
- Pedestrian safety,
- Passenger safety during pick up or set down,
- Safer driving and parking conditions, and
- Better use of limited on-street parking.
Designated parking areas and time restrictions are used to help regulate parking to ensure vacant spaces are available. If you drive or ride a vehicle, please be aware what parking restrictions mean and how to follow them correctly. For information on parking restriction and signage: http://www.rms.nsw.gov.au/roads/safety-rules/road-rules/parking.html
CBD Parking
Here's a map of parking areas across Cessnock CBD.
Cessnock Local Traffic Committee
Roads and Maritime Services (RMS) has delegated installation of certain traffic control devices on Regional and Local roads to the Councils of NSW. Matters relating to state roads or functions that have not been delegated to Council's must be referred directly to the RMS.
To exercise its delegation, Council is required to have a Local Traffic Committee and to refer relevant traffic control matters to the Committee. Rather than having decision-making powers, the Committee is primarily a technical review committee. It advises Council on matters for which the Council has delegated authority to make decisions on, such as parking and traffic management.
Council is not bound by the advice given by the committee, however, if Council does wish to act contrary to the unanimous advice of the committee or when the advice is not unanimous, it must notify the RMS and the NSW Police and wait 14 days before proceeding.
The Committee, chaired by a Councillor, is made of local representatives including Police, transport providers, RMS as well as the State Member.
The Committee considers reports investigated and prepared by Council Officers and makes recommendations to Council on the installation of regulatory traffic control devices on Regional and Local roads that are enforceable by NSW Police.
The Committee has no powers or delegation to act on illegal driver behaviour or non-compliance with road rules such as speeding, hooning or use of unregistered vehicles. These matters should be reported directly to NSW Police.
Further Information
Should you have any other traffic queries please contact Council's Customer Service Officers on (02) 4993 4100.
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Hi Guys,
I went ahead and purchased a new Ableton Push less than a week ago. Got it 2 days ago, and it worked fine when I originally set it up. It installed the firmware update, and worked like a charm.
Turned it on for the second time today, and it seems the unit isnt getting any USB power? It needs to be plugged into a mains adapter to turn on, and it's stuck in "demo" mode when this is done. When connected to my Mac mini 2012 it is not being recognized as a device.
I have tried several USB cables, including the one that came with the unit, which worked originally. I have tested other devices such as a Maschine MK2, external soundcard, traktor x1 etc... everything else is working fine as usual.
I have just sent ableton an email asking for help, but I figured i would check here in the mean time to see if anyone has any help.
Any advice would be appreciated.


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In celebration of Art IS Education this month here is a list of arts resources from PBS LearningMedia. Use these resources to engage students in arts explorations throughout the month of March. Also check out the KQED art contest and consider participating.
KQED Art School Contest
Create a portrait of your favorite person or historical figure. Be sure to include your hometown and state and a one sentence description of the person you are paying tribute to in your cartoon portrait! Entries should be inspired in some way by Sirron Norris's KQED video demonstrations of drawing cartoon faces that convey emotion and consider perspective. The winning artwork, selected by Sirron Norris himself, and the winner will be featured in an article on KQED.org and receive a signed artwork from the artist! Deadline: All entries must be received by Monday, March 31, 2014, at 11:59pm. Contest Guidelines
Bridgeman Library
These PBS LearningMedia resources include images of paintings, cultural artifacts and photography.
Art School
Art School is a video series that introduces contemporary artists who discuss their careers and intentions, then demonstrate hands-on techniques or concepts.
This collection of video segments and lesson plans focuses on "making" in science, technology, and the arts. Teachers can use these resources to encourage do-it-yourself and hands-on exploration in their classrooms.
Spark: Art and the Environment
This Spark collection focuses on artists whose environmental concerns are apparent in their work.
Arts in the Renaissance
This collection of video segments provides examples of Renaissance music, dance, and drama.
Spark: Home
This collection contains short videos about working, contemporary artists who infuse their own culture or their family's culture into their art practices. These videos help address both visual arts and social studies content standards.
Annie on Broadway
This engaging collection of arts resources immerses students in the world of ANNIE and provides a up-close look behind the scenes of a major Broadway musical.