“Chef of the Future” – Can Humira “Core a [sic] Apple”?
Based on the style of their “Chef of the Future” late-night TV commercial, Ralph Kramden and Ed Norton, of classic TV’s “Honeymooners” fame, would most certainly be tempted to add the following characteristic to the miracle-like TV commercial claims of Abbott Laboratories’ drug “Humira”: “Oh, it can core a [sic] Apple.” After all, Humira apparently provides safe and successful Lifestyle-Renewing Treatments to sufferers of several chronic, auto-immune and incurable illnesses including Moderate to Severe Crohn’s Disease, Moderate to Severe chronic Plaque Psoriasis, Moderate to Severe Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis, so, coring an Apple should be a breeze, right?
As a 25-year sufferer of severe Crohn’s Disease, I hate to be a cynic about such miracle positive lifestyle-reclaiming drugs but thus far in my 48 years of Life I have learned that what looks too good to be true, almost always is. There are few exceptions and when you are fortunate enough to come across them, you marry them, cash them in or just marvel at your luck, dust yourself off and keep going. After all, life can be broken down into a few simple rules: 1. There is no free lunch; 2. Never play cards with a man called Doc; 3. Don’t ever eat at a place called Mom’s; 4. You don’t blitz Peyton Manning; 5. Her ass always looks great in those jeans and in any others she asks about; and 6. One (1) drug cannot possibly safely treat Six (6) different incurable chronic illnesses and in the process give these patients back normal lifestyles as easily as the “kitchen gadget” invented by Messrs. Kramden and Norton could open cans, core apples, and sharpen knives.
Humira as Crohn’s Disease Treatment May Come @ Too Costly a “Price”
However, the polished “slice-of-life” Viagra-like TV commercials for Humira could easily influence physicians and their patients to think that these treatment claims are infallible and worse, that these treatment results come easy. Sure, Abbott Laboratories, the manufacturer of Humira, adds in all sorts of background verbal medical disclaimers but people suffering from these crippling, pervasive and lifestyle-swallowing diseases want so badly to believe what they are being shown that they are subconsciously led by their eyes to see themselves in these slice-of-life actor portrayals. As a result, we/they don’t listen to the voluminous amount of verbal horrific medical disclaimers concerning potentially life-threatening respiratory and cancer side effects/complications. It is almost like a magic trick where the slight of hand creates an illusion in which we want to believe. Or, simply taken at face value, these Humira TV commercials are merely signs of the times and unintended manipulations of a society where we have become so lazy and prone to Attention Deficit Disorder (“ADD”) that 140-character Twitter Feeds are being used as Mainstream News Headlines. With my apologies to ADD sufferers, I’m writing this to tell you that at least in my experiences with Humira, there is no free lunch and now that Abbott aggressively promotes its surreal active/normal lifestyle-permissive treatment claims to five (5) other chronic, incurable illnesses (for a total of six (6) diseases to which it is effective against), logic seems to indicate that Humira is too good to be true, at least with respect to Crohn’s Disease.
“Oh, the price you pay, oh, the price you pay,
Now you can’t walk away from the price you pay.” Bruce Springsteen
Think of how an effective chemotherapy (“Chemo”) drug for cancer is typical “advertised.” To that point, I am presently on Chemo for treatment of the Lung Condition known by the acronym “BOOP” which my doctors believe I contracted as a result of being on the Anti-TNF Agent drugs such as Humira for treatment of my severe Crohn’s Disease. (The Condition’s formal name is: Bronchiolitis Obliterans with Organizing Pneumonia.) The Chemo drug being used to treat me is called “Cytoxan.” Have you ever heard of Cytoxan? Have you ever seen TV commercials about it? When my doctor told me they needed to use Chemo to treat my BOOP because the Jerry Lewis-sized mega-dose of Prednisone, the preferred manner for treating BOOP, was not working and the side effects of taking 60 MGs of Prednisone a day for the better part of one year (tapered down gradually along the way) was more likely to kill me than to help me, do you think I asked my doctor to specifically put me on a Chemo drug called “Cytoxan”? The answer to all of the foregoing three (3) rhetorical questions is naturally NO but the aggressive TV commercial campaign for the drug Humira is seemingly being handled such that the patients will in fact seek out Humira to hopefully effectuate the lifestyle being promoted to them. Do you think that is ethical? Is it manipulative of patients too eager for solutions to their problems?
With most Chemo drug treatments, there is a chance that the patient will go through hell regardless of the specific drug used, hopefully to come out the other side free of the cancer and able to resume their life and lifestyle. But some unfortunate people acquire such serious side effects and complications from the Chemo that they don’t make it. These folks tragically either die or must go through more Chemo with different drugs (and/or supplementary Radiation treatment) hoping to slow down their cancer so that they can get the upper-hand before it is too late. Still, others are brought to the brink of death by the Chemo to battle the cancer all the while not knowing whether “almost dying” is actually part of the Chemo treatment/survival process or whether it is a horrific pre-cursor to failure of the Chemo drug and the almost certain onset of death.
In such an instance, would the company making the Chemo drug advertise it on television like it was an Erectile Dysfunction medication with prime time TV commercials showing actors resuming active patient lifestyles of playing tennis, having sex on demand, working, vacationing, etc.? Perhaps the more ethical question is whether or not such a drug should even be advertised to patients because in their desperate attempts to overcome their cancers these vulnerable and very sick people are open to any legitimate-looking drugs or treatment programs which could possibly or probably cure their cancer and return their lives back to them. To that end, a slick, well-produced prime-time TV commercial showing how virile they can be would most certainly influence their decision and demand to undergo treatment with this particular promoted “miracle” Chemo drug. Notwithstanding the foregoing “human nature” analysis, many medical professionals would argue that it shouldn’t be advertised or promoted to patients because of this “human nature” desperation and vulnerability to be so influenced.
In practice, the more likely (and I would argue ethical) approach than the one being utilized by Abbott with its drug Humira is that any new Chemo drug would be shared with the medical community via published articles with scientific data and possibly with a few REAL Patient testimonials as opposed to Actor portrayals of Patients. The “possibilities” of successful treatment vs. the “probabilities” of successful treatment would be weighed and assessed and any such “sharing” or publication would necessarily include data-backed medical side effects/complications information. This ethical strategy begs the question: What is Abbott Laboratories doing with Humira by advertising it to the end-user patient when doing so is at best manipulative of understandable patient (and physician) aspirations and objectives of getting out from under the debilitating, vice-like grips of Crohn’s Disease?
While I find writing on my Blog to be therapeutic and helpful to other sufferers of Crohn’s Disease, I don’t like writing this type of entry which could possibly upset many hopeful Crohn’s Disease patients taking Humira or any of the other “Anti-TNF Agent” drugs (i.e., Remicade or Cimzia) because these medications are very effective in treating Crohn’s Disease (at least they were in my situation by placing my Crohn’s Disease into “in-active” status [i.e., Remission] and keeping it there). However, at least in my case, and in several other Crohn’s Disease cases around the world which I have learned about via the social media platforms which I frequent, the improvement in your Crohn’s Disease could come at a price your body cannot afford to pay in terms of possible lethal Upper Respiratory Infections, Conditions and/or Diseases.
An Increase in Long-Term Upper Respiratory Infections/Conditions/Diseases due to Anti-TNF Agents
Whether it is any specific drug of the aforementioned three (3) Anti-TNF Agent drugs or the cumulative effect of patient usage of any combination of them, these possible lethal Upper Respiratory Infections, Conditions and/or Diseases are now being seen with greater frequency and intensity by doctors who treat patients with Crohn’s Disease. It is unclear if this is because these drugs were rushed into the marketplace after initial success coupled with very little negative side effects/complications such that their usefulness was then expanded to help alleviate other particularly pervasive and difficult illnesses such as Crohn’s Disease and it is only NOW that medical researchers are learning about the possibly higher chances of negative longer term effects of Anti-TNF Agent treatment. (Note: Abbott Laboratories secured FDA approval for Humira so Abbott did nothing wrong by bringing the drug to market as the FDA approval process is rigorous.) But to quote the classic song, “For What It’s Worth,” by Buffalo Springfield, I respectfully submit the following: “There’s something happening here, what it is, ain’t exactly clear.” While it is not clear, some patients taking Humira have died due to fungal infections and others, like me, are being diagnosed with Upper Respiratory problems which are so severe that they require frequent hospitalizations and ultimately Chemo to treat them.
My Humira & Anti-TNF Agent Drug Background
By way of brief personal background with Humira and Anti-TNF Agent drugs, I took Humira from approximately October, 2005, through July, 2009. I took Remicade for almost a year before it and Cimzia for approximately 18 months after it. My Upper Respiratory problems and systemic medical problems did not start until I was in the middle of taking the Humira. Once I read about other Crohn’s Disease patents on Humira with similar symptoms who discontinued the drug and then discovered that their Upper Respiratory problems subsequently disappeared, I asked permission of my Gastroenterologist to similarly discontinue the Humira. After gaining his approval and stopping the Humira, within a few weeks ALL of my Upper Respiratory problems miraculously STOPPED, or so I thought (see April, May 2011, Lung Surgery and August, 2011 Hospitalization re: BOOP below).
In response to recently informing a prominent physician member of the medical community of my current medical predicament (and he is intimately familiar with my specific case of Crohn’s Disease), he emailed me the following compassionate note which was consoling (and sincerely appreciated) but also seemingly representative and reflective of what is being seen NOW by the medical and research communities as a byproduct of the possible premature enticing lifestyle treatment claims made by Humira [emphasis added with bolded-blue underline]:
I continue to be very upset with the cascading sequence of medical events that come your way. I have always felt that we are so desperate for answers (relief) that we unconsciously represent new agents in a bright light. I feel it represents the lack of really good answers which is our quest.
Humira/Anti-TNF Agents & the Lung Condition “BOOP”
More specifically regarding my current medical situation, after a few hospitalizations in April and May, 2011, for Recurrent/Atypical Pneumonia and then for severe shortness of breath, I underwent Lung Surgery for the purposes of obtaining several lung biopsies as a contrast-enhanced CT scan revealed that my lungs were badly damaged. The CT scan seemed to reveal an inflammatory component to the lung damage almost as if I were exposed to dangerous chemicals which prompted such a reaction. This uncertainty ruled out doing a Lung “Scope” because the Thoracic Surgeon required room to maneuver once inside me and a Scope limited him in this manner. As a result, on May 9, 2011, I underwent full-blown Lung Surgery.
Having been hospitalized for my Crohn’s Disease over Two Hundred (200) times and surviving almost Twenty (20) major surgeries, I was surprised at how much this May 9, 2011, Lung Surgery scared me because things at this local suburban hospital were moving along normally in terms of my “journey to diagnosis” but once the results of the contrast-enhanced CT scan came back it was as if my world had changed and there would be no going back to simpler times when I only had to deal with the all-encompassing physical, medical, psychological, financial, emotional and social aspects of severe Crohn’s Disease. That is to say, my plate was already full dealing with potential devastation on a variety of these fronts either daily, weekly or monthly. What was more distressing, however, was that the doctors were each telling me different diagnoses when they came to speak to me privately. Only one (1) of the seven (7) doctors told me to investigate the Anti-TNF Agent drug connection and to eventually gather all of my tests and reports to bring to my New York City Crohn’s Disease Gastroenterologist as she had never seen what the CT scan was showing up on my Lungs and she was quite experienced treating Infectious Disease. I hung on her every word because it made sense and I knew such actions would be my ultimate salvation but I still had to get through the conclusions and instruction of the other six (6) doctors.
The pre-CT scan typical suburban hospital morning rounds with my doctors was fairly casual but the day after the CT scan I woke up to seven (7) different doctors huddled over me asking me to sign various surgical consents while they explained to me that I could have early stage Lung Cancer. At least that’s how it all appeared to me but, truth be told, the Thoracic Surgeon was extremely personable and he took as much time as I needed to understand what was happening. He explained that the possibility of finding Lung Cancer was something he was required to tell me given what was present on the CT scan but he made sure he communicated to me that he would be quite surprised if that in fact was the case.
Despite the surgeon making me feel better, the sudden change in the seriousness of my situation was almost palpable in the air and the resulting looks on the faces of the doctors made me concerned. No longer were the arrogant physicians comfortable in their roles as God as they didn’t know what was wrong with me. And God would know, right? I realized I’d never actually been in a room with several smart doctors who were as baffled by my condition as these doctors seemed to be. But I’m also smart enough to recognize that “being baffled” was what bothered them instead of “being unable to help me.” These were the big shots in the local hospital and their God Memberships were now being tested. Therefore, but for the complicated CT scan images; I was invisible to most of them.
The May 9, 2011, Lung Surgery revealed that I have a rare Lung Condition known by the acronym “BOOP” as its technical term is: Bronchiolitis Obliterans with Organizing Pneumonia (i.e., “BOOP”). I am singling out Humira in this Blog Entry because it is the Anti-TNF Agent Drug I took for the longest period of time, it started my serious Upper Respiratory Problems (i.e., for which I had to be hospitalized) and Humira is the Anti-TNF Agent drug being aggressively marketed to patients and heralded as an effective treatment for at least Six (6) Chronic, Incurable Auto-Immune illnesses.
The surgical team also saw inflammatory and possibly irreparable damage to the lower lobes of both lungs which had been there for quite a while. They gave me very little information about the prognosis for this area of my lungs. As per custom, the surgeon also took several cultures to explore the possibility of fungal infections and then the Pulmonologist went back to playing God and downplayed the entre situation as merely a run-of-the-mill case of “BOOP” which could easily be treated with a Year-Long heavy dose of Prednisone eventually tapered down. In other words, page 198 of the Suburban Pulmonologist’s Textbook addressed this scenario but I wondered if it also factored in my Crohn’s Disease, 25 years of having such a severe case of an auto-immune illness, 25 years of being treated with immuno-suppressive drugs and several years of being treated with Humira and other Anti-TNF Agent drugs.
I didn’t have to wonder long because the ease with which these doctors quickly shifted gears to almost all hang their suburban hats on the diagnosis of BOOP made me a bit hesitant about this “summary” diagnosis. I had no tangible evidence with which to question them but it was like they were busy running errands and at the dry cleaners they paid for their ticket but then left the store without the dry-cleaned clothes. In that analogy, I was the forgotten-about dry cleaned clothes as these doctors feared how not knowing what was wrong with me would reflect on their respective diagnostic capabilities whereas they should have focused on how they were going to use the surgical biopsies and observational information to now help me beat the BOOP.
Treating BOOP with Prednisone
Having been on Prednisone at various times for my Crohn’s Disease, I knew what was to be considered a heavy dose for my body so when this local Pulmonologist suggested we start at 40 MGs a day I told him that such a dose was not analogous to the heavy dose BOOP seemed to require as a jump-start. More specifically, 60 MGs a day seemed to be more appropriate for my body (my knowledge about BOOP was strictly from Goggling it but I got the feeling he was again reciting a formula out of a textbook and it bothered me so I decided to get more “hands-on”). The other doctors in the room listened to me and after a consensus among them they put me on 60 Mgs of Prednisone a day and I was told to see this Pulmonologist in 2 weeks for follow-up care. Mind you, I was not looking forward to being on such a high dose of Prednisone as I did not want to look like Jerry Lewis did when he was battling a similar problem a few years ago and his face got so heavy that it was grossly distorted but my breathing was so strained that after walking up or down a small flight of stairs it felt as if I was desperately sucking air out of a pencil-thin straw.
At first, the 60 MGs of Prednisone helped my breathing but within a few weeks it was as if I was again on no medication. This is when I gained an awful amount of respect for Jerry Lewis as he did what he had to do and couldn’t care less what people thought about his appearance from the Prednisone. With this new found resiliency for being grossly overweight, I started seeing this local Pulmonologist to try and get some answers. Did I need to be on more Prednisone? Did I need to be on other drugs? Did I need Breathing Treatments to break up the congestion in my lungs? At the same time I was also consulting with my long-time Gastroenterologist in New York City who grew increasingly concerned that I had contracted the BOOP as a side-effect of the Humira and/or Cimzia. In other words, the “harmful chemicals” my body was exposed to (often a necessary component of BOOP causation) was the Anti-TNF Agents themselves. He then told me about the lethal fungal infections that were being discovered in patients like me who had Crohn’s Disease and had taken Humira so he had me tested for Histoplasmosis, one of the more common fungal infections. Thankfully, I tested negative for it. However, my Breathing was getting worse and I was losing confidence in the local Pulmonologist.
Due to the rules and benefits of my Health Insurance Policy, it was financially prudent for me to keep seeing the local Pulmonologist but my consultations with him became downright strange as he saw no connection between the Anti-TNF Agent drugs and the BOOP. In fact, each time I brought up my Crohn’s Disease he put up his finger and started shaking his head “No” like some bratty child who refused to listen to reason. Even more bizarre, if that is actually possible, the last time I saw him he told me that he was thinking of taking me off of the Prednisone and letting the BOOP heal by itself. While I had read about some people being treated like that as in rare instances BOOP has been known to go away by itself, it seemed wholly inappropriate in my case when you could hear my chest wheeze from 25 feet away and breathing after walking 10 feet or after trying to carry on a normal conversation felt like running the NYC Marathon.
Different strokes for different folks, I suppose. He is a nice man and I am sure he had my best interests at heart but he was also not listening to me during our consultations and he refused to acknowledge the new and potentially serious lung symptoms I tried to describe to him. Considering I go out of my way to be respectful of all physicians who treat me by writing down my questions beforehand, acquiring copies for them of all relevant tests to make their job as efficient as possible, etc., I refuse to tolerate doctors who won’t reciprocate by simply listening to me. Seriously, if he wasn’t going to listen to my description of various potentially intensifying nighttime lung/wheezing/coughing symptoms, why was I obligated to pay him for his expertise?
Lastly with regard to the local Pulmonologist, I respectfully told him that I was going to seek a Second Opinion in Manhattan. I added that I felt as if we didn’t “connect” and that these things happen sometimes. He had put me on the defensive in such an awkward manner that I felt as if I was “breaking up” with him! I wanted to say, “Don’t feel too bad, it’s not you, it’s me …” but he had zero sense of humor. But then he asked me for this new doctor’s name. In the interest of full disclosure and because I wanted to get out of his office without any confrontation, I told him her name and then he said he’d like to speak with her BEFORE I met with her so he could explain my case to her. I wasn’t sure why he wanted to do this but his “controlling” nature had now pushed me into “Consumer-Mode” and I politely told him that I do want him to contact my new Pulmonologist, PERIOD, as that would only serve to taint the 2nd Opinion Consultation. I felt like Jerry Seinfeld trying to explain the concept of the “reservation” to the Rental Cart clerk who had given away his Reserved Car.
I added that if she needed information from him, she would contact him. He looked at me like he was shocked I had actually made a good point and then his arrogance and God-like aspirations got me angry. I guess upon reflection I thought more about him wanting to speak to my 2nd Opinion Doctor and I wasn’t convinced he was going to heed my preference that he not contact her and that infuriated me especially since I felt like I had wasted a month under his Care. However, I controlled myself and told him that if he contacted her I would report him to the Medical Board because he would be infringing upon my right to an honest untainted 2nd Opinion. He backed down quickly and my “pushback” seemed to unnerve him as his hands started shaking and he fumbled as he put together my records for me. As I walked out of his office I realized I had accomplished my goal; I had broken up with my Pulmonologist.
Treating BOOP with Whatever is Necessary
The local Pulmonologist was now out of the picture so I needed a compassionate and comprehensive Pulmonologist who had experience with BOOP and Anti-TNF Agents. Luckily, my New York City Gastroenterologist had seen more of these types of cases than any other Crohn’s Disease Gastroenterology Practice in the country (and possibly in the world) due to the longtime existence and worldwide reputation he and his partners had built up over the past 40 years. To that end, he referred me to a Pulmonologist in New York City and after meeting with her in mid-June, 2011, I felt for the first time as if I had a “team” of doctors dedicated to getting me healthy as opposed to a group of doctors each staying in their respective “specialty lanes” myopically doing their jobs and only treating the aspect of my BOOP for which they were responsible. There is a BIG difference between the two (2) types of treatments as any chronically ill patient will tell you. In this instance, it was crucial that ALL of the following be factored into treating me for BOOP: my Crohn’s Disease; 25 years of having such a severe case of an auto-immune illness; 25 years of being treated with immuno-suppressive drugs for same; and several years of being treated with Humira and other Anti-TNF Agent drugs. Between my new Pulmonologist and my Gastroenterologist, I knew I was finally on the direct path to successful treatment of the BOOP.
My new Pulmonologist confirmed the link between BOOP, Crohn’s Disease and Anti-TNF Agent drugs like Humira and she added a variety of Breathing Inhalers to the Prednisone as a more well-rounded treatment plan aimed at easing my breathing woes and making me somewhat less dependent on the Prednisone as the Inhalers also had steroids in them. I was told to expect a slow, gradual improvement over a period of MONTHS accompanied by a gradual taper of the Prednisone (sped up a bit after introduction of the Inhalers) such that within a YEAR of being diagnosed with BOOP I should be much better. The only serious worry at this point in time was if scar tissue had already formed in my Lungs because there is no treatment to break that up. Outside of an undetected lethal fungal infection or the BOOP just not responding to the Prednisone and possibly even getting worse, that would be the worst case scenario and I figured I jump off that bridge when I got to it. So in June, 2011, the hope was for inflammation in my Lungs which would be substantially reduced by a Jerry Lewis-like Prednisone regiment for approximately ONE YEAR. I figured if Mr. Lewis could go on International Television looking like a Blowfish, I could at least roam the streets of New York, New Jersey or Los Angeles with my head help up high – and wide!
It’s funny how your self-imposed touchstones of “acceptability” change when you battle chronic illness. Some might argue that a more rigid approach is required to more properly process reality but I disagree because my reality, especially during this experience with the BOOP, is so far from normal that in order to get through each day without getting depressed, I chose to embrace the ridiculousness and unrelenting bizarre nature of my luck or lack thereof. However, in July, 2011, with my breathing NOT getting better, I had gained 40 pounds from the Prednisone and my latest blood work report had so many red warning markings on various measurement levels that for a few seconds after I opened up the envelope I wasn’t sure if I was looking at my most recent blood work or at an early draft of a Brad Pitt-Angelina Jolie Prenuptial Agreement. In any event, it was becoming increasingly clear that the Prednisone was causing more problems than it was solving. While I was familiar with its side effects, I had never taken such a high daily dose so the side effects were intense. For example, I was border-line Diabetic (reversible once I stopped the Prednisone but disconcerting nevertheless), hadn’t slept more than two (2) consecutive hours in months and my vision was weak and blurry. The Prednisone also caused my Sleep Apnea to get ramped up, it brought on Migraine-like headaches and at times I experienced joint pain so painful that I was brought to tears. Whether it was the BOOP or the Prednisone, it was in July, 2011, when I began to think that even if I survive this “Battle of the BOOP,” there’s bound to be residual damage and I could wind up losing the “War.” After fighting so hard to beat this lung condition, I couldn’t let that happen. But the treatment for the BOOP thus far was extreme, unforgiving and seemed even cruel sometimes. What to do?
When all else fails I turn to Google as if my fantastic team of doctors may have missed something that I will find on Google. I know, pretty stupid BUT there was something different about my BOOP than the cases I had been reading about on the Web. Therefore, I figured I might stumble onto something while trying to find some answers that, in turn, would help my doctors, help me. I started reading about the FDA’s August 2009 “black box label warning” for Humira in which it said that users should be aware of “an increased risk of lymphoma and other malignancies in children and adolescents.” As explained to me, a “black box label warning” is the most serious warning the FDA can require for a prescription drug. I even came across the following FDA You Tube Video entitled, “Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade,” regarding the lethal fungal infections associated with Humira. Suffice it to say, I felt as scared every day in July, 2011, as I did that morning in May, 2011, in the local suburban hospital during morning physician rounds when seven (7) doctors woke me up to sign surgical consent forms as they had to operate on my lungs and obtain biopsies ASAP.
Pneumonia Again, Hospitalized Again, enter Chemotherapy to Treat BOOP
Finally, in early August, 2011, a break in my case came when I AGAIN came down with what appeared to be Pneumonia. For most people this would be an un-welcomed development but in my situation I knew it would make me hospital-bound where I would be closely monitored by a variety of specialists because either something was wrong besides just having BOOP or my body required much different treatment. Regardless, I was waking up each day with Fevers in excess of 103 and combined with the coughing and severe joint pain, I just knew that I had to be monitored 24/7 as I was literally afraid I would die in my sleep. The possible finality of it all got my mind wondering how I went from being an athletic person to a 48-year-old man who might have to soon lug around a canister of oxygen with him for the rest of his life, if he is lucky enough to even be alive in six (6) months.
But, the more I thought about it, the more it made sense in the grand scheme of things. I had benefited from the Anti-TNF Agent drugs and because of Humira my Crohn’s Disease had been in Remission such that for lengthy periods of time I got to enjoy a relatively healthy lifestyle free of the day-to-day Crohn’s Disease concerns. Well, now the time had come to pay the price. (Coincidentally, I did have some serious “mechanical” problems such as Adhesions related to prior Crohn’s Disease surgeries and as a result I underwent successful corrective surgeries in August, 2010, and December, 2010. However, each surgery had nothing whatsoever to do with my Lungs. I just have horrible luck when it comes to my health.)
“Oh, the price you pay, oh, the price you pay,
Now you can’t walk away from the price you pay.” Bruce Springsteen
During the August, 2011, Pneumonia development, my Pulmonologist could not have been nicer and more accommodating and she and my Crohn’s Disease doctor agreed that I needed to be Admitted to Mt. Sinai Hospital in New York City as my Breathing was becoming even more stained, the Prednisone was causing potentially life-threatening side effects and I was waking up every day with high fevers averaging above 103. Obviously, when you have symptoms like that for even one day, you should call your doctor. However, in my case, I was on such a high dose of a potent immuno-suppressive drug (i.e., the Prednisone) that I figured these side effects were the “norm” or the horrific experience I had to endure in order to beat the BOOP. Yet, I am still the best judge of my body and I just knew that something was wrong or something wasn’t being done that should be done to help me recover from the BOOP. Having read the FDA “black letter label warning” information and seeing the aforementioned FDA You Tube Video regarding the lethal fungal infections associated with Humira, I was concerned and wanted to make sure that I was checked out for EVERYTHING since some people who had taken Humira HAD DIED because they let their Upper Respiratory problems get out of control. I am not ready to die so I was thankful that Pneumonia stepped in to dictate the next step.
It was August 9, 2011, and I was admitted to Mt. Sinai Hospital in New York City via a LONG overnight stay in the Emergency Room (“ER”). The ER was jam-packed with Hospital Beds stacked up in the hallways waiting for Room Openings like airplanes approaching a busy airport during a snowstorm circling the clouds awaiting word from the Air Traffic Controller when it was their turn to land. It was clean and the medical attention was just barely appropriate since the staff was stretched to the max but I felt like one of those patients in a Disaster Movie who gets the Terrorist-enabled Smallpox disease early in the Film so he must be quarantined but the “safe” area is too small to comfortably house the amount of people affected by the smallpox attack. Accordingly, I kept looking for Dustin Hoffman to come into the ER in some white protective jumpsuit and gas mask to get me out. He never showed so I guess I was no more than an “Extra” in that Disaster Movie.
Again, it was a surreal experience and it all emanated from having injected me with the Humira. You can say that I was warned via the verbal disclaimers set forth in the aforementioned TV commercials but at what point does the POSSIBLE risk of coming down with a life-threatening Upper Respiratory Condition, Infection or Disease turn into a PROBABLE risk of coming down with a life-threatening Upper Respiratory Condition, Infection or Disease and thus outweigh ANY Disclaimers?
During my Ten (10) day stay at Mt. Sinai Hospital a very personable and bright Hematologist was brought on board to my “team” of doctors to consult as to the appropriate treatment moving forward. They were treating the Pneumonia and it was getting better but treating the BOOP was the ultimate goal as they viewed the Pneumonia as a serious side effect of my further comprised immune system due to the high dose of Prednisone I was taking to treat the BOOP. Clearly, my damaged lungs did not need additional challenges and therefore the Pneumonia was an unacceptable side effect and for this and several other reasons my team of doctors started to compile the most effective Plan B. To that end, I was told by my doctors that in cases like mine where the BOOP is caused by an underlying chronic inflammatory disease like Crohn’s Disease and/or by its treatment with Anti-TNF Agent drugs, Chemo is the preferred treatment when Prednisone is not effective and/or it causes counter-productive side effects. After reviewing a variety of Chemo drugs and analyzing how they might affect me, the Hematologist suggested the drug “Cytoxan” as the Chemo drug and my Pulmonologist and Gastroenterologist both agreed. Plans pertaining to administering the Chemo quickly began to take shape and barring unsatisfactory blood level readings (as my blood will be monitored at least every 2 weeks), the plan is to administer the Cytoxan intravenously every three (3) weeks for approximately four (4) to six (6) months.
Given that I have a history of bizarre reactions to immuno-suppressive drugs, the doctors administered the first Chemo treatment in the hospital so that they were able to monitor me for 24 to 48 hours after the infusion. I was also given intravenous medication to offset the apparent nausea which could accompany the infusion of Cytoxan. However, I never got nauseous but I did experience stifling pain in both knees and the infusion somehow triggered what felt like a Crohn’s Disease flare-up. Thankfully, these side effects are manageable as they wore off in a few hours (however the knee pain actually got worse a few days later). I was discharged from the hospital a few days later and I now must begin the exhaustive administrative work associated with such a long hospital stay and to assess the least expensive manner in which to proceed given my current Health Insurance Policy. Obviously, I will have no choice as to any substitute drug and I imagine the Cytoxan is very expensive but I do have some other choices which could affect my financial bottom-line such as where my blood is drawn, getting the infusion in the Hospital or in the doctor’s office, etc.
Humira, Possibility/Probability of Upper Respiratory Problems & Verbal FDA Disclaimers – What is Sufficient?
I have been extremely descriptive in my foregoing explanation of my having contracted “BOOP” from the Anti-TNF Agent drug Humira because I want people to have as much information as possible so that they can assess their own situation. Just like the doctors, I don’t know, nor am I qualified to know, if Humira will cause these types of Upper Respiratory problems in every Crohn’s Disease patient. But as a business person, I can tell you that the manufacturers of Humira might have to soon evaluate whether the required FDA Warnings and Disclaimers accurately portray the risks of Humira patients eventually coming down with lethal Upper Respiratory problems.
I also understand that they are a company in business to make a profit and along the way they and others like them have helped us with other drugs so I am not so quick to judge them. BUT, it’s hard not to do so when you go through all I have been through with this Lung Condition where Breathing after minimal exertion feels like sucking air through a pencil-thin straw. Moreover, while lying in my hospital bed I got enraged at the barrage of Humira TV advertisements targeted at Crohn’s Disease patients as they seem no more credible than good old-fashioned Snake Oil salespeople taking advantage of chronically ill patients so eager to learn of such lifestyle-salvaging treatments for their illness that they will make deals with the devil at the mere possibility of success which they define as a return to “Normalcy,” at least as they knew it. Since we all know, however, that the “devil’s in the details,” I thus felt compelled to share MY STORY to let other Crohn’s Disease Humira Patients know what could be possible for them in the not too distant future.
As such, PLEASE take this Blog Entry in the Spirit in which it was written because I don’t want to affect the “Hope” you have with taking Humira and enhancing and/or resuming your pre-Crohn’s Disease lifestyle. That said, at least there now exists a “play-by-play” account of someone who has been negatively affected by Humira and/or the Anti-TNF Agents. And just like I pray that Humira works for you and your lifestyle without ANY complications, please reciprocate by praying for me that the Chemo rids me of the BOOP. Thanks. (Below is an informative Disclaimer about my Opinion re: Humira. I think it will also add further credibility to me and clarity to my issues with Humira.)
Disclaimers regarding the SOLE OPINION of THIS “Moderate to Severe Crohn’s Disease Patient,” Michael A. Weiss
I must go “third-person” here to mimic the seemingly never-ending verbal medical disclaimers in these “slice-of-life” Humira TV commercials (and in all other Humira Print Advertisements) in which the participants are most likely played by actors instead of by those patients who have been successfully treated with Humira and avoided the warned about Upper Respiratory Problems. In that regard, below is Important Safety/Credibility Information regarding the SOLE OPINION of THIS “Moderate to Severe Crohn’s Disease Patient,” Michael A. Weiss:
I am writing about my OWN EXPERIENCES and cannot represent that what has happened to me happens to all Crohn’s Disease patients although, through the various Social Media platforms in which I am an active participant, I have met many Crohn’s Disease Patients who had to stop taking Humira because of the severe Upper Respiratory Problems they were encountering as a result of being on the Anti-TNF Agent drug.
I am not a Doctor nor am I medically trained. My only medical experience is as a result of my 25-year battle with Crohn’s Disease which has thus far resulted in over Two Hundred (200) Hospitalizations and Twenty (20) surgeries. (From a practical perspective, once could thus argue that I may actually know MORE than most physicians with respect to the “Patient Perspective” of Crohn’s Disease!)
In 2001, I wrote a critically-acclaimed Book entitled, “Confessions of a Professional Hospital Patient,” which chronicled my battle with Crohn’s Disease, both in and out of the Hospital. I have been told the Book uniquely captures the plight of the chronically ill and does so in an inspiring and entertaining fashion. The Book has become an “Evergreen” seller because it extends to managing all chronic illnesses and also due to its positive and candid portrayal of this increasingly common chronic plight. Additionally, reviews of the Book to this day say it is “laugh out loud funny” and “hilarious;” characteristics not typical of non-fiction books about Managing Disease. (I’m not sure this Paragraph belongs in the “Humira – Michael A. Weiss Disclaimer” section but I think it provides insight into my intentions and “patient credibility.” In short, “my aim is true” and I am dedicated to the long-term aspects of Patient Advocacy.)
I took Humira from approximately October, 2005, through July, 2009. It worked very well in treating my Crohn’s Disease until early 2008 when the joint pain I experienced exacerbated and began to make me feel like a Voodoo Doll being stuck with needles by the Cast of TV’s “Celebrity Rehab” the night before they checked in with Dr. Drew to get sober. The pain was all over my body with no mind as to time, place or social appropriateness. It literally brought me to my knees in the middle of conversations with friends and this systemic effect of such a Crohn’s Disease “treatment” then began to concern me.
In mid- to late-2008, I began experiencing severe, recurrent and drug-resistant bouts of bronchitis and pneumonia and even had to be hospitalized at the end of 2008 for shortness of breath, non-stop coughing and extreme flu-like symptoms. As I recall, there were also 2 or 3 emergency room visits for extreme shortness of breath in 2008 and 2009.
In early 2009, after testing normal and negative for all sorts of breathing, pulmonary and asthma tests, I read about other Crohn’s Disease patients who had similar symptoms and experiences with Humira but their debilitating symptoms disappeared when they discontinued the Humira. Accordingly, I sought and was granted permission to discontinue the Humira from my gastroenterologist and within only a few weeks my Upper Respiratory Problems DISAPPEARED. (A few weeks or months later, in August/September, 2009, I was placed on the drug “Cimzia,” another Anti-TNF Agent Drug, as it is thought to be easier to tolerate for Crohn’s Disease patients who had allergic or negative reactions to Remicade and/or Humira.)
I am 48 years of age and was an athlete all my life. I was not a smoker and only started getting serious Upper Respiratory Problems once I started taking Humira in and around October, 2005. I’ve always lived in metropolitan cities such as Los Angeles, CA, the city suburbs of New York and in Northern New Jersey so I have not been exposed to the fungal infections referenced in the Humira medical disclaimers which apparently originate on farms in the Midwest of the United States.