Clinical Trials - To be or not to be?
The summer before I entered high school I started experiencing symptoms such as abdominal pain, diarrhea, and severe weight loss. After a routine diagnostic group of tests I was diagnosed with a severe case of Crohn’s Disease. After diagnosis, I was immediately started onan extremely high dose of steroids and stayed on it for years. I started a chemotherapeutic agent and powerful immunosuppressant. I became increasingly immunodeficient from all the medications I was on. I tried everything to try to alleviate pain and symptoms. I tried the holistic route. I changed my diet. You name it, I have been on it. I stayed on these medicines for years in hopes that they would miraculously begin to start working and all my pain would disappear. Each time I tried a different “promising” drug it was in hope that my misery would subside. And after each drug failed me, my optimism began to fade.
For the majority of my life with Crohn's Disease, I have been desperate for anything to work. I've been on every medicine available (at the time) for Crohn's Disease. I've repeated drug options in the hope that maybe they would work the second or third time. Nothing worked for me at the time. I was willing to try anything, understanding what the risks were, but desperately seeking relief. Prior to having my last surgery, I participated in clinical trials for Crohn’s Disease. My gastroenterologists at the time was heavily involved in research for IBD. So together, we thought participating in clinical trials could be beneficial for me. This was a while ago, so I don’t remember many exact details but I do remember participating in at least two clinical trials. The first one I participated in was for an oncology drug (I don’t even remember what it was called.) All I recall is that, at the time it was used for the treatment of cancer patients. For this trial, I learned to administer the medicine myself. I gave myself a shot on my stomach either once a day or every week (I don’t remember the frequency). I do remember not noticing a difference in my symptoms. It could be that the medicine did not help or I could have received a placebo. A placebo is used in a clinical trial as a control in testing new drugs. This means you are not receiving the actually medicine. The second clinical trial I participated in was for Humira. I remember this trial because I saw a vast improvement almost immediately after beginning this medicine. This also meant I was receiving the drug and not a placebo. I was diagnosed in 1998, at that time, biologic medicines were very new. As a matter of fact the only biologic available was Remicade. It was so new my pediatric doctor at the time refused to put me on it because he didn’t know much about it. Anyway, I participated in a clinical trial for Humira, because at the time it was not approved for Crohn’s Disease. My physician believed I was a great candidate for it. And he was correct. I immediately started showing signs of improvement. I had never experienced anything like it. I thought, FINALLY this is my miracle drug! I was so unbelievably excited! After years and years of unsuccessful treatment options, something finally worked. So you can imagine how incredibly depressing it was for me after not having access to it once the trial was over. After completing the trial, my doctor prescribed Humira for me, but because Humira was still not approved for Crohn’s Disease, my insurance wouldn’t pay for me to receive it. My doctor appealed and eventually I received the medicine. But by the time I finally received Humira I had built a resistance to the drug and it was no longer as effective. During the course of treatment while on a biologic it is possible to build antibodies to these types of drugs and the immune response can change and the effectiveness of the drug or how the body reacts to the drug can then change.So needless to say, that was a constant physical and emotional battle! I remember being in the pharmacy on my knees in tears after finding out I wouldn’t be able to receive the medicine. This happened EVERY single time, after each successful appeal, my insurance would deny the next dose. It was tough, but we were tougher and continued to fight.
To me, part of fighting and overcoming your disease is being an informed patient. Educate yourself about your diagnosis and treatment options. Be an active member of your health care team. Do your own research know your options, know what’s coming down the pipeline, know what you need to do to have the best quality of life. I’ve spoken with many patients in the past about some medicines, biologics, and clinical trials and how for many, one of the big reasons they refused to take them or participate in them was because of the side effects or the “what ifs.” I understand the concerns that many have about medicines and the side effects they cause. Crohn's and Ulcerative Colitis are very complex diseases and require complex treatments. The medicines we as patients have to take to treat IBD are a big freaking deal. They can alter or suppress your immune system or immune response. Yes, the same immune system we rely on to fight off any and all sickness. That could of course come with a lot of associated risks. I understand the concerns you may have about medicines, but because of the severity of my disease I don't understand some of the choices. Some people may have the option to not take something because of the side effects but others don't. Options to treat IBD are very limited. And for many, the options available may not help to treat or alleviate symptoms at all.
As a patient, prior to my surgery, I'd exhausted all medicinal therapies so when the opportunity to participate in a clinical trial came about I was eager to participate. And because of my participation I found something that worked for me. There are clinical trials available an effort to create more treatment options for patients, like myself, that may not respond to traditional therapies. Despite my life and history with Crohn's I still have an insatiable thirst for hope. I still hope for newer medicines and therapies. I work and understand science to know advances are made every day. In a way, participating in clinical trials has the potential to help other patients much like myself and helps to advance science in developing new treatment options for patients. It is a way to provide hope for others living with IBD and maybe provide hope for yourself. Had I not been ready and willing to participate in a clinical trial I may have never found a medicine that worked for me, I may have never experienced that brief moment of hope, if only for a little while.