Breaking News: Humira Approved for Ulcerative Colitis!

Today, it was announced that Humira can be used for people with ulcerative colitis (inflammatory bowel disease). Although, I do not suffer from colitis but from Crohn’s I am happy now more patients will have access to a drug that has really helped me (no pain since June!). Perhaps the post I did back in August maybe persuaded the FDA! The panel decision of 15-2 made it pretty clear that the drug should be approved. As I said in that post the FDA really has no business telling patients with chronic diseases what drugs they should or should not use. Often these patients have more and better knowledge than bureaucrats.

 Humira is an $8 billlion drug that is already used for things like Crohn’s, psoriatic arthritis, anklosing spondylitis, plaque psoriasis, and juvenile idiopathic arthritis. I hope the drug is approved for more uses (I have a feeling Humira could help other autoimmune diseases not sure which ones though). Humira is pretty simple to use. You can go onto the forums and other blogs that describe how scary it is but it is a piece of cake (especially if you have gone through a horrible disease like Crohn’s or ulcerative colitis). The injection stings a little bit and really just feels like you banged your skin against something hard. I put band aids over where I inject it to be safe and ripping off the band-aid hurts more than the Humira injection! Today makes a day we have improved the world just a little bit more.

Antibiotics, Kids, and Crohn's

In this recent article it could be possible that antibiotics increase the risk of inflammatory bowel disease (IBD) in kids. According to the article, IBD has doubled over the past 10 years. The study followed more than 1 million children. The kids that were treated with antibiotics were more than five times likely (84% increase) to get IBD then those who never got the antibiotics. What is interesting is that when kids were given antibiotics at older ages they had an increased risk of getting IBD but not as much. The theory of why this may happen may be due to the fact that antibiotics kills both good and bad bacteria.

I am somewhat sympathetic to this argument (although not 100% convinced). Growing up I had what they called isolated asthma and had a history of getting sinus infections (usually in the spring and fall). Usually I was prescribed antibiotics to treat these colds or sinus infections. As I mentioned in my personal story of Crohn’s my history right before Crohn’s. Right before I had Crohn’s I had bronchitis and my doctor over the phone prescribed me some antibiotics (at first I thought the drugs I was given contributed to Crohn’s however I learned later that they actually helped). I wasn’t getting any better and started to have the diarrhea (which was a side effect of the drug I was taking). Never in a million years would I have guessed it was Crohn’s. My gastro doctor diagnosed me with irritable bowel syndrome (IBS) in February of the same year. My internist believes that it may have sped up getting Crohn’s. I personally believe me working out vigorously, not probably eating the best, and taking antibiotics for years had something to do with getting Crohn’s. Throw in maybe some genes (nearly all my family suffers from some type of autoimmune disease) and we have a recipe for Crohn’s. My goal is to one day know what caused my Crohn’s. 

Bone Marrow Helping Crohn’s Patients

In this recent article it is speculated that Crohn’s and colitis could be treated with bone marrow.  Pam Fraker of Michigan State University was one of the lead author’s of these results in the current issue of the Proceedings of the National Academy of Sciences. Fraker theorizes that if it were possible to reduce bone morrow’s ability to produce inflammation then it could reduce the severity of Crohn’s and colitis.

In June it was announced here that the Fred Hutchinson Cancer Research center was doing a study on allogeneic transplants for Crohn’s patients. What they essentially were doing is replacing the diseased immune system for a healthy one.  It should be known that in the United States there is a shortage of bone marrow (causing innocent people to die). In the United States it is illegal to sell bone marrow (which creates the shortage). The problem is anyone can claim they want to donate bone marrow. However there is nothing binding the person who promises to give bone marrow to actually give it. A website MoreMarrowDonors.org is trying to fix that by offering $3,000 scholarships, housing allowances, and other incentives to get people to donate. If people had more incentives there would be more bone marrow which would lead to more experimentation which would give us more knowledge about not only Crohn’s but other diseases as well. 

Jennifer Jaff and Life Expectancy with Crohn’s

I saw this recent article  about Jennifer Jaff who had Crohn’s since she was 19 and recently passed away at the age of 55. This would say Jennifer had Crohn’s for around 36 years.  In just a 12 year time period Jennifer had 8 surgeries and gained 120 pounds on steroids. In addition to all this at one point in time her kidneys began to shut down. What is really scary is I read this recent New York Times article that talks about how kidneys and other organs are being completely discarded.  I would rather compensate people for their kidneys in order to get more and better kidneys however that is a whole different issue.

Jennifer was a lawyer (trial lawyer in the 1990’s) who earned her law degree at Georgetown. In my experience Crohn’s patients typically seem to be well educated but I would need more data to prove that. Jennifer fought for patients rights and didn’t want insurance companies to discriminate against people with chronic conditions. I disagree with this however since I believe insurance companies should charge prices that reflect their risk. People with more health care problems will cost more than people with fewer health problems no question. On a side note I find most Crohn’s patients to be liberal although I am a libertarian (even before I had Crohn’s) because I believe the government should not tell me what prescription drugs I can or can’t take. Just think how much better off if marijuana could be studied for Crohn's patients. I am all for taking something if it will improve my health. We live in a time where we have more medical knowledge than ever yet the FDA still finds ways to make the process of creating a drug not only burdensome but in some ways make drugs that are too safe. A few major problems with healthcare are consumers are not able to go across states to purchase healthcare, the FDA decides what drugs can or can’t be used, and the American Medial Association (AMA) determines who or can’t practice medicine. If people were allowed to buy insurance across state lines, if the FDA only checked the safety of the drug and not the effectiveness of a drug, and if the AMA was abolished we would have more doctors which would all decrease the cost of medical care.

I was curious about life expectancies and Crohn’s. According to this meta-analysis (combined studies) life expectancy for men with Crohn’s was 77.3 for men and 79.0 years for women. However, if patients were diagnosed before 20 then the life expectancy was reduced to 64. What is really interesting is that the life expectancy of regular people is 71 for males and 77 for females. We shouldn't jump up and down and say wow Crohn’s makes us life longer (or should we?)  I was diagnosed when I was 25.33 years old.  I personally believe Crohn’s may lead to lower life expectancy considering your body is in a state of inflammation but with new technologies like pig worms, Naltrexone, and SSI as possible future treatments for Crohn’s the future does look a little brighter. Perhaps once genome technology becomes cheaper we could see if certain genes led patients to more surgeries, flare-ups, or complications.

Weight Loss on Crohn's and Family Health

I haven’t blogged in a while been busy with work and studying for an exam in my industry. I am still doing well on the Humira. I actually have lost a couple of pounds (I did voluntarily because I felt I was getting big). These days I weigh around 156 lbs (no clothes).  I blogged on August 16, 2012 of my weight gain here and forget I was 162 a little over a month ago. My work clothes and regular clothes seem to fit better and I wear a size 34 waist even though I have been 32 nearly my whole life (when I came back from the hospital last November my mother had to purchase new pants because I was down to 127 pounds.  For the past couple year before Crohn’s I was 145-155 lbs and never really got out of this range.

I noticed though that my bowel movements went from over 1 to .6 movements per day. I wonder if eating less has anything to do with it. In general I have been avoiding dessert at night and eating salads and healthy things for lunch. Usually my family goes out to eat on Saturday night and we have Mexican food on Sunday (so I do gain some weight back). As time goes on I am becoming less convinced that Crohn’s has to do with diet. Of course some foods can aggravate people who have Crohn’s. However, until this point I haven’t really found anything in particular. The only thing I do notice is sometimes when I eat something very rich and chocolate it gives me a little pain (although I think I had this same pain pre-Crohn’s). Speaking of pre-Crohn’s I honestly feel like I did before Crohn’s which makes Humira a wonder drug indeed. 

My twin sister came back from the doctor this week and she may have hypothyroidism (autoimmune disease). Our doctor noted it was interesting that almost my whole family has an autoimmune disease (except for my mother). My father has hypothyroidism and as you know I have Crohn's. My father said he took penicillin for years which caused him to become allergic to it and now can't take any medication that is penicillin based. My twin sister also has acid re-flux which everyone else in my family seems to have except for me (I don't drink wine or soda though). In a strange way I think some of these things are connected however I just don't know what or exactly how they are connected yet. 

Soligenix and Crohn's Patent

Today Soligenix was granted a patent to produce a topical agent to treatment for treatment in pediatric Crohn’s disease. It should be noted that pediatric Crohn’s is a little different than Crohn’s in adults due to the different issues that are faced with younger patients (height, health, weight). The drug works with beclomethasone dipropionate which works in the upper and lower gastrointestinal tract. The drug has been used since the 1970s and Soligenix is trying to develop an oral form of the medication. The company will start trials that should be started this year on SGX203 (oral form). Hopefully another future drug that can be used in the drug arsenal against Crohn’s!

Pig Whipworm Treatment for Crohn's and Autoimmune Diseases?

A recent news story came about pig whipworm treatment for Crohn’s. Basically the idea is that the worms is based on the “hygiene hypothesis” which basically states that autoimmune diseases are higher in countries with higher levels of sanitation. In countries that are not as sanitized they are exposed to parasites which seem to make autoimmune diseases less likely. In a related note recently Coronado Biosciences (maker of the genetic pig whipworm) was granted a patent that doesn’t expire until January 2029. According to the clinical trial information here the trial should be complete by August 2013. A partner of Coronado, called Dr. Falk Pharma GmbH is also doing a clinical trial that will be completed by December 2013 (however it began in November 2010).

This news story from ABC talks about a man who actually ingested the worms and felt better. The 33 year old man ingested 2,500 worm eggs every 2 weeks for 3 months (the man had the disease since he was a teenager). What is interesting is that most of his Crohn’s symptoms disappeared. For those grossed out by worms they are microscopic and can't be seen in water. In fact the guy who took the worms just said it tasted like salty water. The inflammation markers in his blood also decreased as well.  He however had to stop because the treatment was costing around $4,500 (mainly since it is not FDA approved ).

A trial is now being conducted by Coronado Biosciences. The company is enrolling 220 patients using 7,500 pig worm eggs every 2 weeks for 3 months. Some prior studies have yielded pretty good results. This study showed that 79.3% of patients showed a response with no adverse affects.  In this study  from 2004 (looked at colitis and not Crohn’s) after 3 months of treatment 43.3% of patients saw improvement. I should point out that the worms were from the United States Department of Agriculture. Treatment in this trial also did not induce side effects. The drug does have the possibility to become a blockbuster as it has shown some promise for other autoimmune diseases such as multiple sclerosis, rheumatoid arthritis, autism, even allergies as seen in this Wall-Street Journal article.

With the large stage clinical trials patients with both Crohn’s and colitis may get another treatment to use in the ever growing arsenal list of treatments. I am pretty sure if I was born in the 1930’s and had Crohn’s I probably wouldn’t be alive today. Hopefully the FDA (US regulator of drugs) will allow this drug as long as it is proven safe. I would rather have patients and not the FDA decide if the treatment works. Knowledge these days spreads like wildfire. With the internet, e-mail, texting, and other technologies we can transmit information so rapidly ye the FDA feels it should regulate medicine like it were the 1950s. Experimentation is needed in a world full of uncertainty. I think Crohn suffers would agree we would eat worms if it made us feel better.

3 Months on Humira: Still Working!

Update: I just recently published a retrospective after being on Humira for 2 years. Pain free since then!

I have been on Humira since June 6, 2012 and it has been 3 months since I took my first Humira dosage. At first I was worried because I thought after the loader dosage I would feel good and gradually get worse since you take 4 shots the first time then 2 and then one every other week. Towards the end of May I was feeling pretty crummy and could barely get out of bed. I was getting weaned off Prednisone gradually but actually I feel better now than I did when I was on 60 mg of Prednisone. Humira really is a miracle drug!  I really wonder how people got by before the biologics were around. I know I saw some literature that showed after a year about 42% of people who take Humira are still in remission. So by definition the odds are I won’t be in remission next June however I wonder if the 58% of people who are not in remission have anything in common.

I thought I was gaining weight on Humira but now am slowly dropping (no vomiting from Crohn’s either Iike I was in May!). The pain in my stomach is different too. Before Humira the pain was sharp like a knife stabbing you and now if I ever have pain it is a combination of feeling hungry and queasy at the same time which is good. Another benefit I have noticed is that embarrassing problem I mentioned in this post is now gone completely. In another post I had mentioned I literally felt a pain in my backside but that however has went away. Perhaps Humira is the gift that keeps on giving. When I was first diagnosed with Crohn’s I spent countless hours online and kept coming across people who believed it was diet. Although, there was some evidence (even peer reviewed) that it may be linked I highly doubt this. From my own experience I know this because I went one week eating no sugar and felt worse. Once I was on Humira I went on a food binge for a week and felt like I was bulletproof. My internist who has an both an M.D. and Ph.D. in biochemistry explained that diet and Crohn’s is garbage which I now believe is true. People forget that Crohn’s is an autoimmune disease and not a diet disease. Given how many obese people we have around the world if Crohn’s was really diet related wouldn’t more than .5% of the world’s population have it? 

Crohn’s and Colitis Foundation (CCFA) 990 Form, Fundraising, and Finances

I was doing some research and happen to find Form 990 for the Crohn’s and Colitis Foundation (CCFA) .The latest year I could find was for 2010. In 2010, CCFA made $45.12 million in revenue and had expenses of $48.3 million. This left CCFA with a deficit of over $3 million. However, in the same year CCFA reported a net worth of $5 million ($22 million in assets and $17 million in liabilities). Around $15.65 million was spent on grants while $3.9 million was classified as “other”. Also close to $3.37 million was spent on postage, mailings, and publications. Is CCFA aware that it is 2012 and not 1992? I am all for getting the word out but aren’t there more effective ways of doing the same thing at a cheaper cost? I also saw the organization redesigned their website this year and wonder how much that cost.

The largest contributor was the Leona and Harry Helmsley Charitable Trust ($3.36 million) in 2010. The trust according to their latest financials in 2011 had $4.1 billion of a net worth. Whenever I read research articles I often see the Leona Helmsley Charitable Trust as a provider of funds. Although Leona married a rich man she was a millionaire in her own right before she married. When Leona died she left $4 billion to the charitable trust. She also left money to her dog “Trouble” but that is a whole other story in itself. Other contributors included Abbott Laboratories (maker of Humira), Ortho Biotech Clinical Affairs, and Carl and Edyth Linder.

Many different schools across the United States received grants. Emory University received the largest grant getting $1.8 million, Massachusetts General Hospital received $879,674, and University of Carolina at Chapel Hill got $632,872.

Even though CCFA is a non-profit the leaders should run it like a business. CCFA has a net worth of $3 million. This really does not leave a cushion in case things get bad. For instance, if the economy got worse people would obviously give less to all charities. CCFA should run surpluses in case they run into some tough years. Also as I mentioned before $3.37 million is spent on postage, mailings, and publications. It could be studied how to cut this amount without losing the message. I am usually not in favor of government spending but would have CCFA try to lobby Congress to study inflammatory bowel disease since it is such a debilitating disease and considering how much we waste (millions of dollars is not even a rounding error in the annual budget) it is a small drop in the bucket. Individuals should also volunteer not only their money but time as well to help educate family members, loved ones and friends about this disease. Heck tell random strangers about it!