FDA Panel and Humira for Ulcerative Colitis

Some good news might be coming for our inflammatory bowel brother and sisters (those who suffer from ulcerative colitis). In a 15-2 panel decision the FDA recommended that Humira would be beneficial for people who take ulcerative colitis. Humira is already approved for six conditions including Crohn’s disease. The FDA usually follows usually follows the panel’s recommendation however they don’t have to like in the case of a breast cancer drug. We will have to wait until the end of the year though to see what the FDA actually decides.  Last November the FDA rejected Abbott (maker of Humira) application to be used for ulcerative colitis. The FDA claimed that the drug did not show that it helped patients.

 The FDA should know that drugs work differently in everyone and no two people are alike. This is why I believe once a drug is approved for safety by the FDA people and their medical professionals should determine if they should take the drug. Not only would this bring in more competition which would actually drive down the cost of drugs but would make patients more aware instead of blindly trusting the FDA.

What is bizarre is why the FDA has to approve whether or not a drug is effective. Patients and doctors are far better at doing this then the FDA panel. My question would be what 2 people on the panel voted not to approve Humira for ulcerative colitis? Do these people have any family members with ulcerative colitis? Do they know what it feels to have ulcerative colitis? If you said “No” to the two previous questions then go to the head of the class. People have a huge incentive over their health especially when it is seriously. I would be willing to bet that Crohn’s and ulcerative colitis patients are in the top 1% of knowledge of the population since they have a huge incentive in knowing how to get better. 

Humira and Fewer Heart Attacks?

Good news just came out for those who are taking Humira (well for at least psoriasis anyways). In this news report it appears that treating psoriasis with drugs that inhibit TNF (tumor necrosis factor) could possibly reduce the risk of myocardial incident when compared to other possible treatments. The way I understand psoriasis is that it is an autoimmune disease like Crohn’s however leaves people with patchy and itchy red marks all over their body which doesn’t seem very pleasant.

 In the study Dr. Jashin Wu looked at treatment information and new diagnosis for 9,000 people with psoriasis. In the study which looked at people over 4 years after treatment there were 3.05 myocardial incidents per 1,000 patient years as compared to 3.85 myocardial incidents per 1,000 patients years. This was also lower than the 6.73 rate for patients who took topical drugs. TNF inhibitors may have a 21% lower myocardial risk when compared to other drugs. TNF drugs are drugs like Remicade, Enbrel, and Humira. Hopefully in the future we will have more of these types of drugs to increase competition.

The question of the hour however would be does this study translate into meaning a lower chance of myocardial incidents for Crohn’s patients? My guess is maybe but since Crohn’s is a gastrointestinal disorder maybe not. What probably should be studied is how anti TNF drugs like Humira, Remidade, and Enbrel lower the chances of having a myocardial incident. 

Tofacitinib Improves Ulcerative Colitis While FDA Delays

In this most recent WSJ article the drug tofacitbin helped improved symptoms for people who had inflammatory bowel disease. The article is published in the New England Journal of Medicine which can be found here.  The doses ranged from .5 mg to 15 mg and were taken for 2 months with a 194 patient population.  The largest response was seen in patients who took the largest dosage (15 mg). In the group that took 15 mg 78% of patients saw a response (response was also statistically significant) and was much higher than the placebo rate.  The only side effect was an increase in both good and bad cholesterol (LDL and HDL). However, I would imagine this could be controlled with exercise, eating right, and perhaps a statin (Crestor or Lipitor).

The drug is being studied to be used in patients with ulcerative colitis however patients with ulcerative colitis take similar drugs to Crohn’s patients. Pfizer (company that makes tofacitibin) is still waiting for the drug to be approved for rheumatoid arthritis and the FDA was suppose to make a decision by August 21 however pushed that back three months to November as seen here.  What is interesting is that tofacitinib would be the first drug approved for rheumatoid arthritis in over a decade. What is even more interesting is that tofacitinib has one of the largest clinical databases for any rheumatoid arthritis drug ever submitted with over 5,000 patients taking it in 44 different countries yet the FDA still needs more time to analyze the drug.

What is encouraging however is that in May a panel of FDA advisors in an 8-2 decision should be approved (FDA doesn’t have to follow panel advice but usually does).  I wonder what would happen if you had a panel of 10 family members of people who either suffered from both rheumatoid arthritis and ulcerative colitis. I would be willing to bet the rent money that that decision would be 10-0 to approve. The FDA panel has no personal experience with these illnesses nor do they see the daily pain that people suffer as the result of these diseases. While I agree the FDA should be in charge of safety of drugs they should in no way shape or form be in charge of how effective the drugs are. By pushing back the possible approval date patients will suffer and be harmed in the process which hardly anyone ever talks about. Also tofacitnib seems much safer than Remicade, Humira, or other drugs. The FDA acts like a cartel deciding what drugs go on and off the market. As a Crohn’s patient I want as many options as possible. Let me as a Crohn’s patient decide what I ingest into my body. After all I do care more about my body than any bureaucrat! 

Endometriosis and Crohn’s

In this study of 38,000 Danish women who were hospitalized between 1997 and 2007 and then tracked up to 13 years after their follow up. More women developed inflammatory bowel disease (ulcerative colitis at a rate for than double Crohn’s).  Women who have endometriosis were 50% more likely to get inflammatory bowel disease than the general population. The woman who had surgery to verify that they had endometriosis were 80% more likely to get inflammatory bowel disease than the general population.  In this study the percent chance of getting inflammatory bowel disease was .8%.

Even though women who have endometriosis are more likely to get inflammatory bowel disease a 50%-80% increase in a disease the disease would still affect relatively few women. Although, it is interesting if endometriosis is causing inflammatory bowel disease. When looking at these studies we have to be careful not to assume X cause Y since the human body is so complex and there are many factors involved. 

Humira and Weight Gain

Recently, I have noticed that I have gained some weight while on Humira. My usual weight is between 144-153 lbs. I peaked a week or so ago at 162 pounds when I went on the scale and just felt heavy. As of today I am 160. My father even made a comment asking if I had a potbelly so I really know I was getting heavy I wonder if the Prednisone is still in my body since I have been on it off and on since November. I can still remember wanting to eat 5 times a day on Prednisone. In an odd way it was almost magical even though I was diagnosed with a chronic disease. Most of my days were just spent resting and I still remember sleeping on the couch for a week or so because my parents were worried about whether or not I had enough strength to climb the stairs. In addition to this I also remember being in search of food and actually got tired of eating really well! Anyways, my face has blown up a little bit with pimples however I think that should go away. I thought my hair was thinning however my hair seems to be thicker than before. Most likely I might visit my doctor just to check and make sure I am not getting dangerously heavy. Although I am 5’11 and weight 160 I just feel big. I have been working out every day and have been cutting back on sweets as well. I wonder in some odd way if the extra weight is helping the Crohn’s. I remember reading about an article about people who had abdominal fat here. Although this scientific article claims that Crohn’s disease is associated with an increase in central fat accumulation although I wonder how much this is due to the medication that Crohn’s patients take. I have really never noticed a large Crohn’s patient most seem to be thin or average weight. I myself was lean before I was diagnosed with Crohn’s and wonder if what I ate over the years and excessive working out had anything to do with it.

 When I first went to the hospital I was as thin as a rail weighing only 125 lbs. When I was younger I was large as a kid up until around 13 or 14 and then I began working out and in college I was somewhat of a crazy person working out every day for at least 40 minutes on the elliptical. In graduate school I continued the same pace on weekends I could go for over an hour on the elliptical and it felt really good burning over 600 calories. If I remember correctly a few times I burned over 700 calories. The calories were flying off but I wasn’t always eating the best things. After my work out I would treat myself to Fuzzy’s (Mexican food) refried beans, followed by a Whataburger with cheese and fries, and then a 7-11 brownie for dessert. I am not going to lie this was food heaven. However, I don’t think it was good for my body. As I got older and even before I got Crohn’s I started trying to eat more salads and fruits and branch out

Crohn's and Pollution: A Link?

I came across this news story that I found interesting. Apparently, Dr. Josh Korzenik of Harvard Medical School seems to have an interesting view of what may be causing Crohn’s. Northport, Washington is a city of 296 people yet has an inflammatory bowel disease rate that is 10 to 15 times normal rates. The city is located downstream from a smelter in Trial British, Columbia.  Apparently, people could smell the population when they were growing up. This is really interesting considering I have read about always read about environmental factors that could affect whether or not people have Crohn’s but never though it could be tied to pollution. I am somewhat skeptical because of this study that looked at air pollution and inflammatory bowel disease and showed that air pollution was not related to inflammatory bowel disease however exposure to nitrogen dioxide and sulfur dioxide did increase the early-onset of inflammatory bowel disease. There is always the possibly that some other factor is causing inflammatory bowel disease especially in a population that is only 296. Also I would be curious to examine what these people eat. Canada which isn’t too far north of this city has one of the highest rates for Crohn’s in the world yet no one yet has been able to figure out why.  However, these people of Northport, Washington should be examined closely to see what clues might emerge that can help us solve the Crohn’s puzzle. 

Ken Baumann and His Secret Life With Crohn's Disease

I recently saw this interview with Ken Baumann who is an actor talking about his Crohn’s disease on Dr. Drew. Baumann is an actor who stars on the Secret Life of the American Teenager. He currently is married and is from Abliene, Texas (small Texas town). It is interesting that his birthday is one day before mine (any correlation with birthdays and Crohn’s?) and he is also like me from Texas.

Baumann had surgery in the spring of 2011 and seems to be doing a lot better since then. For Baumann he had part of his small intestine and one foot of his colon removed. It is great to see that he is doing much better after surgery since the idea of Crohn’s is to keep it in remissions as long as possible. As Dr. Drew in the interview points out we have made many advancements in the treatment for this horrible disease and if Ken Baumann and I were both living 100 years ago we might not be living.

Many famous people have Crohns disease. Such people include former U.S. President Dwight D. Eisenhower, Beverly Hills 90210 star Shannen Doherty, NFL quarterback David Garrard, lead guitarist Mike McCready, and music star Anastacia. Plus this also doesn’t include the number of people who have the disease who have not gone public with it. It is good when stars talk about their disease because the public then becomes more aware about it. Although I never wish anyone would get Crohn’s in an odd way the more people that get it the more we can study it, research it, and possible find a cure for it. If you have Crohn’s disease be sure to inform others about it and maybe even possibly tell complete strangers to get the word out.

Crohn's and Xifaxan (Rifaximin) and New Venture for Salix

It was recently announced that Salix Pharmaceuticals will pay $25 million in addition to $10 million ($35 million total) to Alfa Wassermann if Xifaxan (rifaximin) is approved for Crohn’s. Currently, Xifaxan is FDA approved but only for traveler’s diarrhea.

In this trial when patients were given Xifaxan and 70% of patients who were not on steroids went into remission. In this very recent study (2011) when 800 mg of Xifaxan was administered to Crohn’s patients twice a day for 3 months (12 weeks) 62% of patients went into remission which is very good and better than biologics like Humira and Remicade given rifaximin has few side effects.

 Xifaxan has been around since 1987 to treat traveler’s diarrhea (approved by FDA in 1998).  One interesting thing I didn’t know was the Xifaxan does not build up antibiotic resistance like other drugs. Also interesting is that the drug is helpful for people with irritable bowel syndrome (IBS). I was diagnosed with IBS in February the same year I was diagnosed with Crohn’s (got diagnosed with Crohn’s in December of that same year). I have always wondered if there was a connection if any. My gastro prescribed hyoscyamine for the IBs and all I really had was a pain in my side. I really just had a pain in my right side.  Right before I got Crohn’s my internist said I had bronchitis and gave me Levaquin, Prednoise, and all in October. I remember with the bronchitis feeling really tired and often just laid on the couch studying cause I really didn’t feel like getting out of bed.  I started having diarrhea right before I took the Levaquin (for a while both my father and I believed this is what was causing me to get Crohn’s). I came home the day before Thanksgiving feeling so tired I honestly don’t remember how I drove to the airport I was so tired.

Honestly, I hope that Xifaxan gets approved for Crohn’s. I have talked before on this blog about how the FDA actually harms people by holding up drugs in development to make sure they are deemed “safe” and effective. I would rather have a system that just looks at the safety and lets patients decide whether or not the drugs are effective. People are different. What works for one individual may not work for another individual. Having clinical tests on small groups of people is meaningless if other people who weren’t even in the group could benefit. Xifaxan seems to be a drug with large benefits and low costs yet the FDA still has not approved it while hundreds of thousands of people suffer every day from Crohn’s. 

Crohn's and Daclizumab

This recent article shows that researchers have found a unique type of immune cell lymphoid tissue inducer (LTi) that may contribute to multiple sclerosis. Now you may be thinking why this is important for Crohn’s patients. Multiple sclerosis (MS) is an autoimmune disease like Crohn’s . I could only find one FDA approved drug that Crohn’s patients and MS both have in common (Tysbari) . However, TNF inhibitors like Remicade and Humira in rare cases can cause MS which is interesting since they are both autoimmune disorders. A trial that ended in this 2007 showed that daclizumab helped patients with multiple sclerosis.

Bibiana Bielekova M.D. found that MS patients who took daclizumab had reduced inflammation and those patients who didn’t take daclizumab had a more LTi cells. What is interesting is that in the research daclizumab can steer the body away from LTi cells. Daclizumab is like Remicade in that it administered intravenously. Although, the only real use for this drug has been for kidney transplants.

What is really unknown is what causes Crohn's. Although we now know more about the disease we really have no idea what causes it which make it harder to treat. With more research and development of new drugs I am know progress will be made to help people who are most troubled by it. 

Crohn's Update: Humira is Working!

Ever since the Humira shots I have been feeling pretty well. Before I took Humira I was a little scared of the injections and the pain people reported. I also remember seeing a YouTube video of a guy that was on Humira and reported how he didn't feel any pain. At first I was skeptical thinking "ya right this guy is joking". Only after a week or so I began to feel better on Humira and I really have not had any pain since. Before Humira I couldn't lay on my stomach cause I was in pain. Now that pain is gone and I can sleep better because of it. I am also skeptical of how diet impacts Crohn's since being on Humira I have let's just say eating things that a nutritionist would call X-rated (donuts, cookies, cake) although I have been eating more salads on a daily basis which may be helping who knows. The only odd thing is that I have had an odd feeling in as Forrest Gump would say "buttox" area. It feels like an itch or pain but I really can't put my finger on it. If it persists I will go to my gastro doctor and ask but it kinda comes and goes and hasn't been that bad. As I mentioned in a previous post I ended up in the hospital (not related to Crohn's) because of a pill I was taking. Right now I am having less than one bowel movement per day and felt like I did pre-Crohn's.

If you read some of the things people write about Humira you would think Humira is horrible and can cause all these side effects, and wonder why anyone in their right mind ever take this drug. People on forums represent a small percentage of what actually goes in in the real world! Even though I have my doubts about the FDA as they hold back medicine that can be beneficial in the name of preserving safety I really don't believe their would be a drug on the market if it was as deadly as people claim. In fact the FDA my be making drugs too safe! Yes, Humira does have side effects and can lead to infections, illness, and even cancer. Again this is a very small percentage of people and the underlying risk and torture of Crohn's also has to be considered. I am thankful that those self-interested greedy capitalists at Abbott Labs (maker of Humira) were self interested enough to make a drug that helps people like me on a daily basis.

Crohn's and Olympics: Connection for Athletes?

With the Olympics here is it great to see someone with Crohn's in representing us! I myself worked out since I was 16 not very hard until I went to college. In college and in graduate school I would work out pretty hard burning 500-600 calories per day and on Saturdays stay on for over an hour. My twin sister who currently does not have Crohn's disease did not work out as hard however what I ate may have been more extreme since I was doing all that working out. Maybe there is some connection between extreme work out and getting Crohn's. I have noticed stories on athletes who have got Crohn's however no one ever talks about a link. It might be possibly due to working out and having a reduced immune system which makes it harder to fight certain things.

Hospital Visit: Not Crohn's Related

Last Saturday night/Sunday morning I was sitting at my desk on the computer when I noticed a burning sensation in my scalp. It felt somewhat odd and I didn't pay any attention to it. A few minutes later I noticed my skin started to feel really warm. I was trying to figure out what was going on. At first I wanted to take a shower but then I realized I was having a reaction to Niaspan a drug I had been taking for a while. I called my doctor (I am with MDVIP which allows patients to contact their doctor 24/7 which comes in handy) at around 3 on Sunday morning. I thought I had hives and he instructed me to take 20 mg prednisone and only go to the hospital if I felt like I couldn't breath. Sure enough 5 minutes later I felt shortness of breath and my parents took me to the hospital to see what was going on. I was surprised hardly anyone was at the hospital on an early Sunday morning. Once I got the hospital things were starting to get better even though I wasn't given anything. My doctor things I felt short of breath because I was nervous and going to the hospital. We had to wait around a little bit and a nurse talked to us and when the doctor came in he told us this can happen even in patients that take Niaspan for years. My doctor told me to take Niaspan with Alka Seltzer and that should help. I want to retake the drug to see if it happens again. I know I can tolerate it but if not I want to visit my doctor to see if he can switch out the drug for something else.

Crohn's and Smoking

According to this article that was just released  people former smokers have a higher risk of developing either Crohn’s or ulcerative colitis as opposed to people who don’t smoke. I have never smoked a cigarette in my entire life and have never drank alcohol, or even soda. Female smokers were 90% more likely to develop Crohn’s and ex-smokers. The longer women smoked the more years had a higher chance of getting Crohn’s disease. What is interesting is that even when people stopped smoking they had a 50% higher risk of getting ulcerative colitis than those who continued to smoked.

No doubt smoking is a waste of time, money, and air. Some of factors for Crohn’s disease like smoking, genetics, and being Jewish are interesting yet I have none of these. No one in my family has ever had inflammatory bowel disease or any other type of gastrointestinal issue. My mother and sister have a mild case of acid reflux and take Nexium however I have (and hope never to develop this).  

Hopefully, researchers can study what irritants in cigarettes create inflammation and maybe find ways to prevent it to help Crohn’s patients. Until then we should all stop from lighting up!