Where Have I Been?
It’s been a while since I’ve “blogged.” I don’t like to share my thoughts with the world when I am depressed nor do I share them about my “day-to-day” unless they involve something interesting, inspirational or instructional to me and to people around the world living with, and trying to manage, some form of chronic illness. I don’t care how I come across in the entry just that I honestly share my health and chronic illness experiences with others for their betterment and hopefully for the betterment of healthcare, in general. While I compile and battle through my “lessons learned,” I encourage you to read other blogs and watch other videos to diversify your knowledge. Crohn’s Disease can be devastating and puzzling and I certainly don’t have a monopoly on the most effective ways to deal with it. But I have to live life in order to obtain my perspective and that’s exactly what I’ve been doing. IMHO, sanity with Crohn’s Disease and chronic illness is all about maintaining Perspective.
As for writing from a depressed perspective, I think it would make for an entry too skewed toward the negative and that’s just not fair for me to represent, given that many, or at least some, people look to me for inspiration and I am a positive person such that it is against my nature to write something that would be depressing for the rest of time on the Web. Complaining about the cards you’ve been dealt in life is akin to crying in a poker game about your hand while playin’ with John Wayne, Robert Mitchum and Paul Newman, circa’ “The Cincinnati Kid.” I say, “Take it like a man [or woman] and play the cards you’re dealt.” Worse that can happen is you will be immortalized like the aforementioned gentlemen. It may be a painful, lonely and boring life, but you will inspire so many and at your funeral the worst people can say is that you were a “Stand-Up Guy [or Gal] who tried to help many.” And there ain’t nothin’ wrong with that. I’ve given a few eulogies in my life and being able to call the deceased a “Stand-Up Guy” who helped everyone he came into contact with made everyone in the audience smile. In such a sad and often tragic setting, that’s pretty cool.
But, that said, I do get depressed but I try to stay away from the computer when that happens. I find a move theater more therapeutic in such an instance because what’s better than getting immersed in someone else’s crappy life, marveling about how Bruce Willis and Harrison Ford never seem to age or how bizarre some aging beautiful, but woefully insecure, Leading Ladies look in High Definition? I leave the theater feeling fantastic about all my scars. So, for those of you who battle chronic disease, it’s okay at times to be depressed. It is just my opinion not to Post at that very moment. If you need to write for therapeutic purposes, by all means do so, just hold it back for 48 hours so you and your inner Editor can make sure it conveys your true intentions and not your secret yearning to be dealt a new set of life cards, for Robert Mitchum will find you and kick your ass back into reality. But if after that 48-hour “Waiting Period” you still think it has value as a Post; go for it and it will stand on its own for all the world to consume. Those are my own self-imposed rules as “Managing Editor” of this Blog, just in case the boys are keeping track on how I’m handling he cards I’m dealt. OK, Cincinnati?
I’ve been reticent the past few weeks/months about my personal details because life has been difficult and I wasn’t sure how to handle or share it. I guess I find it easier to tell a story after I’ve been through it so I can point out my mistakes, share my successes and learn from both. Otherwise, a blog can become a verbal “real” Reality Show and I tried to TiVo “Crohn’s Disease” last night and not much came up (but I SWEAR that someone in Los Angeles, CA has been working on a Reality Show for people with chronic diseases). I can’t ask anyone to understand that but I try to avoid making my life a “reality show” unless sharing medical happenings in real time is paramount to the story I want to tell because I write this Blog for the purposes of helping people looking for “something” to help them make sense out of living with chronic illness, especially an illness so odd, badly “marketed” and misunderstood as Crohn’s Disease and other Inflammatory Bowel Diseases (“IBD”).
The only exception to this is when I am battling a uniquely severe Crohn’s Disease “flare-up” which I think would help others, a long hospitalization for anything (since being a hospital patient is an experience like none other) or going through the process of Chemotherapy (which is just brutal and these days can affect MILLIONS all over the world). Unfortunately, I’ve added the Chemotherapy exception because I have had to go through it for the second time in 2-3 years for a yet un-explained lung disorder or disease which, after a surgical lung biopsy, keeps coming up as me having “necrotic tissue” [i.e., dying tissue] in both lungs for which some of the most respected medical institutions in the United States have yet to explain despite their best of intentions to try and help me.
I’m working hard toward getting such an answer but that “journey,” like most in healthcare which seek answers to unprecedented questions, is proving to be a long, dark and lonely journey. (Just so you know, this lung “problem” causes Severe Shortness of Breath such that I must live like fictional aging/sickly character “Hyman Roth” in the film “Godfather II” so as to not aggravate my lungs and I also get intermittent “fever attacks” of 105 degrees of temperature. I get such severe headaches from the 105 fever that I usually start to hallucinate. But they go away after 6-8 hours so basically they remind me of the fun nights at college. Still … .)
The Fine People you meet along the Way
As part of my journey, this spring I found a remarkable female Pulmonologist in New Jersey who might just be the most competent and thorough doctor I have ever met (sorry Dr. Mark Chapman but she’s much easier on the eyes that you are as a Brian Dennehy look-a-like!). She’s the quarterback of my situation (but with Crohn’s Disease likely a part of the problem, Dr. Chapman is directly involved) and that now includes infusion of the chemotherapy drug, Cytoxan, once a month for six months by another extremely smart Hematologist/Oncologist. But, all of my doctors agree that at some point SOON I must go to National Jewish Health, the number ONE respiratory hospital in the United States. The slight complication is it is located in Denver, CO and the high altitude there will make it even more difficult for me to breathe. That’s why the Chemotherapy already started in June, 2013 and the kind folks in Denver, CO have also started the screening process so they can soon see me for at least a week and hopefully diagnose what no one else has been able to do. Then everyone can discuss the proper current treatment and any after-care medication. I don’t worry about anything and just trust my cards, I mean, my doctors.
Why? Really. I think, it’s the Biologic medication, Humira
In MY OPINION based on MY EXPERIENCE (that’s MY lawyer-speak to protect me from getting sued for all that I own, which, when you think about it, isn’t much at all but I disdain wearing suits and going to court), I think this rare and complicated lung problem I have has something to do with, or is directly caused by, the Biologics drugs I took for my Crohn’s Disease, most notably the drug “Humira,” the one I was on for the longest period of time. I never had respiratory problems before I started Humira and only suffered SEVERE hospitalized respiratory problems AFTER I took Humira. To figure Humira has nothing to do with my lung problems is like not understanding the concept of physical attraction after spending just a few moments with the beautiful and engaging actress Rachel McAdams and then going home to your Mom and not having that same almost animalistic feeling. But then you see a picture of Ms. McAdams again and “the fire inside” instantly lights up. This before and after, or “ipso facto,” as jurists might refer to it, means, “by the fact itself.” Now let me try it in a sentence: I took Humira for my Crohn’s Disease for a rather long period of time and ipso facto I have a severe lung problem. It is damn possible if not likely or logical.
Respiratory Problems are noted as potentially FATAL Side Effects of Humira (i.e., Fungal Lung Infections) but Humira is SO NEW that the manufacturers, Abbott Laboratories, and the Food and Drug Administration (“FDA”) simply don’t know for sure whether that is true for every Crohn’s Disease patient, if there is a predisposed patient genetic component to contracting such side effects nor do they know which respiratory problems are exactly to blame for such Humira side effects. However, upon first learning of such frequency and severity of Humira side effects, the FDA issued its “STERNEST” regulatory admonition called a “Black Box Warning” which required Abbott Laboratories to comply with the contents of the Black Box Warning by listing “disclaimers” about these side effects on the Humira “packaging.” This is seemingly a solid regulatory plan but, like almost everything else in life, the devil’s in the details, and in reality, what is, and what is not, listed on the “packaging” of Humira is negotiated by Abbott and FDA lawyers.
Okay, that’s life and each party has legitimate business and regulatory interests motivating its negotiating strategy but when is “packaging” ever of consequence to a Crohn’s Disease patient eagerly anticipating his or her last opportunity at successful treatment of going into Remission when all other conventional drug therapies have been exhausted? Do they sell Humira in supermarkets like shampoo where savvy shoppers can compare packaging labels between such potent Biologics? This scenario was keenly recognized by the FDA and in an attempt to reach as many patients as possible with an important Humira-related Black Box Warning, the FDA went where most patients go, i.e., to YouTube. Thankfully, the social media dinosaur that is the FDA had the smarts to have its high-level executives read the aforementioned Black Box Warning on YouTube. For this, I commend the FDA on their efforts to reach as many Crohn’s Disease patients as possible with such social media activism.
Banks & Sub-Prime Lenders /Pharma and the FDA?
While Pharmaceutical (“Pharma”) lawyers and drug lobbyists in good faith attempt to comply with the FDA’s latest “sternest” warnings about early or current patient possible frequent and severe side effects of Humira, they are paid to negotiate or “influence” them down such that they are minimally legal compliant with the FDA’s “stern” warning so as to not negatively or adversely affect the drug’s allure to prescribing doctors and desperate patients as the “Miracle Drug” they portray Humira to be on their TV Commercials. The FDA, on the other hand, is motivated to bring a drug like Humira to market because it “possibly” provides an answer to incurable illnesses and struggling patients with no other choices. But is the FDA “pressured” to “come to the rescue” perhaps prematurely? Is that wishful and well-intended premature approval or Pharma financially-fueled possibly premature approvals for drugs like Humira? The philosophy behind this match of Pharma and the FDA’s regulatory authority is not all that different from that forged between Banks and Sub-Prime Lenders a few years ago which ultimately almost brought down the ENTIRE United States and possibly WORLD economy.
Who Represents Crohn’s Disease Patients at FDA Humira Regulatory meetings?
“Let’s Make a Deal” Game Show Host Monty Hall could probably better explain what actually goes on behind closed doors between the FDA and some Pharma companies looking to quickly bring a drug like Humira to market. But who represents the Crohn’s Disease patients during these negotiations which are potentially rigged against the Crohn’s Disease patients themselves? To that end, a gregarious and smart doctor I met at a speech I recently gave in New York City tried to explain this to me by advancing the notion patients have every right to be at such FDA “regulatory hearings” as they are given “Advance Notice” in the Federal Register.
Given this “Advance Notice,” I asked him how many patients showed up at the last FDA Hearing regarding expanding the approved usage of Humira to certain Ulcerative Colitis (“UC”) cases and he said NONE. But he added there were at least 37 doctors in attendance each of whom presented cases of the use of Humira in UC cases which resulted in positive outcomes with no side effects. I remarked the UC patients on Humira who developed Ovarian Cancer, Lymphoma, Liver Damage and Lung Disease must have missed that edition of the Federal Register. He looked at me with a condescending look likely thinking, “Oh well, just another bitter patient,” until I explained to him that patients read the Federal Register about as frequently as he reads the pornographic magazine Jugs – although given my luck I may have coincidentally been wrong! Seriously, the FDA got it right when they turned to YouTube because these days educated chronic disease patients congregate on various health care social media platforms and by posting important Humira Black Box Warnings on YouTube, the FDA will eventually reach the affected/interested patients. But the Federal Register?
Humira TV Commercials – a Patient Education Program? NOT!!!!
Have you seen Abbott’s omnipresent Humira Network Television Commercials? Does a level of FDA-induced “candor” described above come across or is Humira marketed more like an Erectile-Dysfunction drug promoting the possibility of regaining a certain positive lifestyle? Does that accurately explain what Humira does for Crohn’s patients? Does it adequately explain the patent risks? The video portion is glamorous for 30 seconds or so but the 30-seconds or so of fast-talking voiced-over side effects Disclaimer is downright frightening when you focus on it. Listen next time. Also, aren’t you also curious, how Abbott Laboratories reacted under such intense Regulatory scrutiny about Humira by the FDA?
Despite the FDA also issuing at least some serious aspects of these Black Box Warnings to the manufacturers of the two (2) other popular Biologics given for Crohn’s Disease, namely, Janssen Biotech, Inc. for the drug “Remicade” and UCB for “Cimzia,” Abbott Laboratories was the only one which, in response, implemented a multimillion dollar US Network Television Commercial Blitz. Here it is: “Humira for Severe Crohn’s Disease.” It seems almost as if Abbott is afraid Humira will soon be taken off the market and they have to make as much profit, as fast as possible. By the way, Janssen and UCD did not at all change the commercialization of their respective Crohn’s Disease drugs. If anything, they both increased their Patient Education Programs, a patient-friendly logical step.
This is the game played between Pharma and the FDA so as to appear legally compliant but to protect Pharma shareholders from patient lawsuits for side effects which aren’t somehow covered by the broad generalized disclaimed ones conveyed to patients by lawyered-up marketing language used by Abbott in all of its promotional materials. Given my experience, the FDA is LOSING this game and they are letting Abbott possibly falsely influence a passive United States TV audience of millions.
Again, I commend the FDA for trying to regulate this drug at each and every turn but with health care social media turning into “word-of-mouth” on steroids, they can’t keep up with the effects of a multimillion dollar Humira TV ad campaign. More dangerously, I think the FDA got snookered a bit when these Biologics were first approved and issued to patients. There have been too many severe and frequent side effects which additional research time and drug modification could have avoided – in my opinion.
But, Humira does help MANY Crohn’s Patients w/ NO Side Effects
Call me crazy, but it is entirely possible that I might just be a Crohn’s Disease patient (possibly one of many) with a Humira-caused respiratory problem which both the FDA and Abbott have never seen before. What else would explain a side effect from such a NEW drug not being detected by such prestigious institutions as the Pathology Department at The Mayo Clinic? Before the drug companies insulate themselves from liability by including every possible “expansive” side effect word in those “voiced-over” TV side effect disclaimer warnings, they must first convince the FDA they are serving a disease constituency of Crohn’s patients with a SAFE drug for whom there is no cure and thus, this is their last hope. In that regard, I must note here that for MANY Crohn’s patients, Humira works as designed with few or no side effects.
But for MANY Crohn’s patients like Natalie Quinn (simply judging from her YouTube Video), Humira either did not work or it caused such severe life-altering side effects that she’d been better off living with Severe Crohn’s Disease, without ever taking Humira. More importantly, many of these Severe Crohn’s Disease patients who have unsuccessfully taken Humira wind up with conditions and diseases much worse than Severe Crohn’s Disease, including death.
By way of the REAL LIFE EXAMPLE bravely submitted by Natalie Quinn to YouTube in a Video entitled, “What Humira did to me!!!!!,“ PLEASE WATCH IT BECAUSE IT reminds me of the FURY of Crohn’s Disease, the potential severity of Humira side effects and how incredibly lucky I am to simply have breathing problems as a possible result of both.
People, PLEASE start paying attention to this phenomenon of Miracle Drugs like Biologics and Humira being fast-tracked by the FDA and THANK people like Natalie Quinn who are the TRUE heroes who battle Crohn’s and all it involves every waking hour of their lives.
This Blog started out as a hobby for me but has wonderfully turned into something much more. I have so enjoyed hearing from other patients and I have learned a great deal from their stories. In that regard, I intend to update the Blog as events warrant but please be patient with me as the Chemotherapy is difficult and gets me so fatigued I can barely keep my head up at the computer screen. I’m also trying to capitalize on the extraordinary early adoption of the “Crohn’s Disease Warrior Patrol” and candidly, THAT is what gets me excited every day because “People helping other People truly can be the best medicine.”
Please keep reading and SHARING YOUR COMMENTS BELOW. Thank you.