Showing posts with label drug interactions. Show all posts
Showing posts with label drug interactions. Show all posts
Friday, August 12, 2011
Night Sweats Redux
After finishing 18 months of treatment involving powerful, side-effect laden drugs one’s expectations are that once you are no longer taking the drugs, you no longer experience the side effects. This does not exactly seem to be the case. Shortly after the first week following the end of treatment, I began to experience night sweats again.
Within a few months of beginning the drug trial in 2010, I started to experience night sweats, as related in this post. The night sweats were intense with heavy sweat soaking through sleeping clothes and even requiring changing the sheets in some cases. These went on for several weeks until my body seemed to adjust to the various drugs and they receded to only an occasional event. This was the norm for about a year until they became a bit more common during the final 8 weeks of treatment. They were still not the heavy sweats that characterized the early part of treatment, but they did happend a few times a month toward the end.
About ten days after finishing treatment, I woke up on my back with a pool of sweat on my concave abdomen (did I mention that I had lost a bit of weight?). After a change of shirt and going back to sleep, I awoke later to the same condition. This happened three times during the night and by morning there were damp shirts hung all over the bedroom. It was unclear why it might be happening. My wife had recently had the flu and I was a bit feverish before retiring for the night so perhaps it was related to that. When it happened each night for the next week, it occurred to me that it might be related to the HEP C treatment. The heavy sweats have stopped, but in a milder form they have remained an event that occurs about 3 times a week.
It is not clear what the cause is. In my darkest moments, I remember that the symptoms for the onset of acute HEP C are flu-like, including fever, sweating and muscle aches. I felt some of them at the start of this round of sweats but it does not seem likely the sweating would have continued on for several weeks after the other symptoms disappeared. In talking to folks who have had relapses after treatment, they report that they relapse within the first month, which would fit the scenario, but they do not report having symptoms. It could also be related to stopping the other drugs being taken to alleviate the side effects of the standard treatment. Ambien was something I was taking every day for the final 2-3 months of treatment as sleep was not something that came easily or often. Ambien is not something that should be taken daily and even Dr. Sue had been more worried about the addictive nature of that than of any of the other drugs I was taking. There are some withdrawal symptoms that are noted for Ambien, but they do not indicate that they would go on for weeks after stopping. It could be that the long term use of interferon and Ribavirin has reset my internal thermostat. It always ran cold before as witnessed by the pile of covers on my side of the bed every night. Perhaps now it is more like my wife’s internal temperature gauge. She often sleeps covered only by a sheet on nights when I am swathed in blankets.
I hope it is something as benign as my body permanently running warmer than it used to. If nothing else, surviving summers in San Francisco will be easier if running hot, than if constantly cold. Until more evidence is gathered, the jury is out. In the meantime I am busy brainwashing myself that it is NOT because of any recurrence of HEP C.
Saturday, October 9, 2010
Minding Your Drug Interactions
Among the disadvantages of being in a drug research study is the tendency for discontinuity in your medical care. The RO5024048 Roche study that I participated in was run by Dr. Natalie Bzowej. It was administered by the Hepatology Center at California Pacific Medical Centers (CPMC). CPMC is a first rate institution and they do cutting edge Hepatitis C research. The doctors are excellent, but as is true with specialists everywhere, they are busy people with many patients. When I screened for the study, I was examined by Dr. Frederick. For early symptoms of rash, sweats etc, I was examined by Dr. Merriman. When I had difficulty with pain issues I was examined by Dr. Bonacini and prescribed Tramadol. Later, when I was having trouble with sleep, I was examined by Dr. Frederick and prescribed Trazadone. When depression issues cropped up, I was examined by Dr. Bzowej and prescribed Paxil. and added Ativan for use as needed. After I reported difficulties with the Paxil, I was seen by Dr. Frederick again and he changed the antidepressant to Celexa Finally, my thyroid function was affected by the research meds and I was put on Levothyroxine by my primary care doctor.
Over time, this can add up to a significant number of medications creating their own set of interactions with each other that have to be carefully attended to. This is something that you should not be leaving solely to the doctors treating you. All the doctors in the hepatology center work on the same team. They are all involved in doing research and, to the limits imposed by patient and study confidentiality restrictions, they communicate with each other and share patient information. However, each doctor has preferred medications they are familiar with and prescribe regularly. This creates a situation in which each doctor is thoroughly familiar with certain meds and they may not be conversant in the effects and interactions of meds preferred and prescribed by the other doctors. You have to do your own research on the drugs you are taking and the potential interactions between them all. I found the drug interaction database at drugs.com to be particularly helpful. If you find something, contact your doctor and get their response. If you feel you need to change drugs, tell them. Keep at it until you get answers that satisfy you.
In my case, I was prescribed tramadol, trazadone and celexa. All have the effect of inhibiting serotonin reuptake in the brain. While this is a good thing for combating depression, if it results in an overabundance of serotonin in the brain, it can cause serious problems: irritability, confusion, tremor, stronger reflex reactions, sweats and potentially even seizures. I do not think these would have been prescribed together if all my symptoms had manifested at the same time. But as each was prescribed for a symptom that was occurring at separate times in the study, I ended up taking them all. There are days when I have to take all three and it is on those days that I have been noticing an increase in my some of my symptoms.
I have increased irritability, a general increase in physical tension and in activities like rubbing my hands, pacing, grinding my teeth, etc. This is all symptomatic of serotonin syndrome which I thought I experienced a few months ago. I am seeing both my primary care doctor and my hepatologist this week and will bring this all up with them both. I would like to see another painkiller substituted for the tramadol and perhaps another sleep aid substituted for the trazadone. I am not sure which way the doctors will want to go but I am tired of feeling this way and need a change.
Over time, this can add up to a significant number of medications creating their own set of interactions with each other that have to be carefully attended to. This is something that you should not be leaving solely to the doctors treating you. All the doctors in the hepatology center work on the same team. They are all involved in doing research and, to the limits imposed by patient and study confidentiality restrictions, they communicate with each other and share patient information. However, each doctor has preferred medications they are familiar with and prescribe regularly. This creates a situation in which each doctor is thoroughly familiar with certain meds and they may not be conversant in the effects and interactions of meds preferred and prescribed by the other doctors. You have to do your own research on the drugs you are taking and the potential interactions between them all. I found the drug interaction database at drugs.com to be particularly helpful. If you find something, contact your doctor and get their response. If you feel you need to change drugs, tell them. Keep at it until you get answers that satisfy you.
In my case, I was prescribed tramadol, trazadone and celexa. All have the effect of inhibiting serotonin reuptake in the brain. While this is a good thing for combating depression, if it results in an overabundance of serotonin in the brain, it can cause serious problems: irritability, confusion, tremor, stronger reflex reactions, sweats and potentially even seizures. I do not think these would have been prescribed together if all my symptoms had manifested at the same time. But as each was prescribed for a symptom that was occurring at separate times in the study, I ended up taking them all. There are days when I have to take all three and it is on those days that I have been noticing an increase in my some of my symptoms.
I have increased irritability, a general increase in physical tension and in activities like rubbing my hands, pacing, grinding my teeth, etc. This is all symptomatic of serotonin syndrome which I thought I experienced a few months ago. I am seeing both my primary care doctor and my hepatologist this week and will bring this all up with them both. I would like to see another painkiller substituted for the tramadol and perhaps another sleep aid substituted for the trazadone. I am not sure which way the doctors will want to go but I am tired of feeling this way and need a change.
Monday, September 27, 2010
Less Anger, More Irritation
Today was more placid than the past several days. The book sale was over save for the cleanup. We made more money than we projected we would. Even though not nearly enough people showed up to help with the load out, it still managed to get done without driving any of us to total exhaustion. Close, but not quite all the way there.
The inner dialogue today was primarily one of irritation and disgust instead of rage and fury. That is a big win from my perspective. Even though none of the dialogue ever reaches spoken form to be judged by others hearing it, it still makes me feel better that, were it to slip out, it would not sound quite so insane as it would have this past weekend.
I still set up an appointment with the difficult Dr. K, my primary care guy to sort out the thyroid situation, as it could not hurt to know the score on those meds. He can check assorted plumbing as well so we will all know just how things look from the bottom up.
Still keeping the knives sequestered and the ammo separated from the firearms by stairs, but the trigger finger is much less itchy today…
The inner dialogue today was primarily one of irritation and disgust instead of rage and fury. That is a big win from my perspective. Even though none of the dialogue ever reaches spoken form to be judged by others hearing it, it still makes me feel better that, were it to slip out, it would not sound quite so insane as it would have this past weekend.
I still set up an appointment with the difficult Dr. K, my primary care guy to sort out the thyroid situation, as it could not hurt to know the score on those meds. He can check assorted plumbing as well so we will all know just how things look from the bottom up.
Still keeping the knives sequestered and the ammo separated from the firearms by stairs, but the trigger finger is much less itchy today…
Sunday, September 26, 2010
Anger Management Revisited
I have noticed that anger management issues are cropping up once again as my chemotherapy drags on. In an earlier post, I talked about the first bout of it I had several weeks into the RO5024048 study. It’s coming back again, though with a decidedly different twist. I am not having problems dealing directly with irritating people, but I am having extended arguments with them in my head. I think this could be attributed to one of two side effects or a third cause that is due my current circumstances.
The first would be depression. I am on Celexa and do not feel that I am depressed. I remember what I felt like before I started on the antidepressants and this doesn’t feel like that. I am a bit tenser than I have been and I have a theory about that I am going to check out this week. I noticed that once I started on levothyroxine for my low thyroid function, I became more jittery than I had been before. There was a bit of an adjustment period when I started on antidepressants but that had leveled out a bit by the time I started on the thyroid meds. I then noticed a definite step up in nervousness when I started taking the thyroid meds. I wonder if my thyroid is working better now and my dose is too high and whether the thyroid meds might be interacting with the antidepressants to make me a bit too edgy. I am calling my primary care doctor tomorrow to set up an appointment to test my thyroid hormone levels and perhaps adjust my dose.
The second possibility is the mental problems that can be caused by interferon and ribavirin themselves. It is a known side effect of this combination of drugs that can include irritability, depression, aggressive behavior, suicidal behavior and suicidal or homicidal thoughts. I have not been thinking about killing myself or anyone else. I have indeed thought about letting a few individuals know what I really think about their attitude and behavior and doing it in no uncertain terms. I have imagined these (admittedly one-sided) conversations in vivid detail. I have not, however, actually done any of this and I have not noticed that my behavior towards others has become more aggressive. I am trying to keep a close watch on this and am going to wait for the results of the thyroid tests and any dose adjustments before I address the issue of whether my antidepressants need to be adjusted.
I do note that my behavior has become more decisive, but no one has mentioned that I have been abusive or angry toward them, and I have been asking for feedback if that happens. I find that in situations start to degenerate into indecisive dithering, I am becoming more apt to step in and tell people what to do. This does not seem to me to fall under aggressive behavior in the way they mean in the side effects description, but I am definitely wary of my reactions and behavior.
The third possibility is that some of this is the result of a long hard seven days of dealing with our organization’s biggest event of the year. I have been working longer hours than usual, in more crowded and chaotic circumstances than usual, doing more stressful work than usual. There is nothing like dealing with the sort of obsessive, picky and occasionally barking mad people that populate a used book sale to drive stress levels to the stratosphere. I don’t believe it is entirely due to this circumstance that I am noticing my inner dialogue moving more to “that stupid little prick” sorts of expressions than usual, but it must have something to do with it.
So until I get to see all my doctors about my meds, the knives stay in the drawers and the guns and ammunition on separate floors of the house…
The first would be depression. I am on Celexa and do not feel that I am depressed. I remember what I felt like before I started on the antidepressants and this doesn’t feel like that. I am a bit tenser than I have been and I have a theory about that I am going to check out this week. I noticed that once I started on levothyroxine for my low thyroid function, I became more jittery than I had been before. There was a bit of an adjustment period when I started on antidepressants but that had leveled out a bit by the time I started on the thyroid meds. I then noticed a definite step up in nervousness when I started taking the thyroid meds. I wonder if my thyroid is working better now and my dose is too high and whether the thyroid meds might be interacting with the antidepressants to make me a bit too edgy. I am calling my primary care doctor tomorrow to set up an appointment to test my thyroid hormone levels and perhaps adjust my dose.
The second possibility is the mental problems that can be caused by interferon and ribavirin themselves. It is a known side effect of this combination of drugs that can include irritability, depression, aggressive behavior, suicidal behavior and suicidal or homicidal thoughts. I have not been thinking about killing myself or anyone else. I have indeed thought about letting a few individuals know what I really think about their attitude and behavior and doing it in no uncertain terms. I have imagined these (admittedly one-sided) conversations in vivid detail. I have not, however, actually done any of this and I have not noticed that my behavior towards others has become more aggressive. I am trying to keep a close watch on this and am going to wait for the results of the thyroid tests and any dose adjustments before I address the issue of whether my antidepressants need to be adjusted.
I do note that my behavior has become more decisive, but no one has mentioned that I have been abusive or angry toward them, and I have been asking for feedback if that happens. I find that in situations start to degenerate into indecisive dithering, I am becoming more apt to step in and tell people what to do. This does not seem to me to fall under aggressive behavior in the way they mean in the side effects description, but I am definitely wary of my reactions and behavior.
The third possibility is that some of this is the result of a long hard seven days of dealing with our organization’s biggest event of the year. I have been working longer hours than usual, in more crowded and chaotic circumstances than usual, doing more stressful work than usual. There is nothing like dealing with the sort of obsessive, picky and occasionally barking mad people that populate a used book sale to drive stress levels to the stratosphere. I don’t believe it is entirely due to this circumstance that I am noticing my inner dialogue moving more to “that stupid little prick” sorts of expressions than usual, but it must have something to do with it.
So until I get to see all my doctors about my meds, the knives stay in the drawers and the guns and ammunition on separate floors of the house…
Thursday, August 19, 2010
Trophy Geezer
I was deep in the throes of TV inertia. Anyone who has gone through Hep C treatment or chemotherapy knows the drill. You are home from work, or have done some work around the house or have just managed to drag yourself through the day and you are tired and you couldn’t concentrate on anything to save your life. You flop (or gracefully settle) down onto the sofa, grab the remote and turn on television, the great savior of the addled, befuddled and fatigued.
Luckily, the brave new world of cable (or satellite or internet) television gives one an almost infinite set of choices of worthless time wasters to choose from. Celebrity Rehab: B, C, D and E list “celebrities” try to get off drugs and use the show to rebuild their careers at the same time; Holmes on Homes: Canadian contractor makes you feel that any work that was ever done on your home was probably both substandard and outright dangerous; Whale Wars: Sea Shepherd staff and volunteers demonstrate a belief that their self-righteous conviction to the cause of saving whales means they do not have to practice or prepare in anyway for their maneuvers until they are in the middle of the Antarctic Ocean (oh, and never bring any spare parts either); Comedy Central Presents: an endlessly supply of comedians you have never hear of doing the same 30 minute set on travel, life in the city, health and grooming habits, how their girlfriend-husband-wife-boyfriend are impossible and then the windup about the perils of sex; all these hits are available for your delectation.
The other day none sufficed until I flipped by John Stewart’s The Daily Show just as he was introducing his guest, Emma Thompson. The lovely Ms. Thompson is my favorite actress and the only woman intelligent, loony and sexy enough that I would leave my wife for her. She was delightful and indeed completely loony during the interview. She went on about the narcissism of Mary Poppins (she was promoting her new Nanny McPhee movie), the practice of raising British children in boxes and never letting them outside when the sun was shining and how she did her scriptwriting longhand and indeed only wrote one letter per page so that her finished scripts were huge stacks of paper. Okay, you had to watching – but I was and it was fabulous.
Later that evening I was describing this to my wife and, for the umpteenth time mentioning that Emma was the only women I would leave her for while adding that there was no danger the attraction would be mutual (did I mention certain saint-like characteristics of my wife), To which my wife replied why not? Why wouldn’t Emma Thompson find me attractive? Flattering I said, but I’m older than Emma, have bad teeth and thinning gray hair and am not a wealthy guy and movie stars generally go for the good looking fit younger sorts, especially if those sorts don’t have money (the trophy wife, boy toy thing). So she suggested that I play the anti-boy toy card. That I be the intelligent, amusing, somewhat eccentric older guy; that indeed, I be the trophy older guy.
That’s when it hit me. I could start a career as Emma Thompson’s trophy geezer, her partner in inspired, insane lunacy. She would have to pick up all the bills of course as whatever talents I posses have never led to money, but she can afford it. And to think, I have my wife to thank for this brilliant idea. My trophy geezer facebook page and twitter accounts should be going up soon as well as the trophygeezer.com website where you can sign up for courses on becoming a trophy geezer and share you experiences on the various trophy geezer forums. And I owe it all to Hepatitis C…
Disclaimer: The events, ideas and descriptions described in the above post may have occurred due to the interactions among the panoply of drugs I am currently taking in my treatment…
Luckily, the brave new world of cable (or satellite or internet) television gives one an almost infinite set of choices of worthless time wasters to choose from. Celebrity Rehab: B, C, D and E list “celebrities” try to get off drugs and use the show to rebuild their careers at the same time; Holmes on Homes: Canadian contractor makes you feel that any work that was ever done on your home was probably both substandard and outright dangerous; Whale Wars: Sea Shepherd staff and volunteers demonstrate a belief that their self-righteous conviction to the cause of saving whales means they do not have to practice or prepare in anyway for their maneuvers until they are in the middle of the Antarctic Ocean (oh, and never bring any spare parts either); Comedy Central Presents: an endlessly supply of comedians you have never hear of doing the same 30 minute set on travel, life in the city, health and grooming habits, how their girlfriend-husband-wife-boyfriend are impossible and then the windup about the perils of sex; all these hits are available for your delectation.
The other day none sufficed until I flipped by John Stewart’s The Daily Show just as he was introducing his guest, Emma Thompson. The lovely Ms. Thompson is my favorite actress and the only woman intelligent, loony and sexy enough that I would leave my wife for her. She was delightful and indeed completely loony during the interview. She went on about the narcissism of Mary Poppins (she was promoting her new Nanny McPhee movie), the practice of raising British children in boxes and never letting them outside when the sun was shining and how she did her scriptwriting longhand and indeed only wrote one letter per page so that her finished scripts were huge stacks of paper. Okay, you had to watching – but I was and it was fabulous.
Later that evening I was describing this to my wife and, for the umpteenth time mentioning that Emma was the only women I would leave her for while adding that there was no danger the attraction would be mutual (did I mention certain saint-like characteristics of my wife), To which my wife replied why not? Why wouldn’t Emma Thompson find me attractive? Flattering I said, but I’m older than Emma, have bad teeth and thinning gray hair and am not a wealthy guy and movie stars generally go for the good looking fit younger sorts, especially if those sorts don’t have money (the trophy wife, boy toy thing). So she suggested that I play the anti-boy toy card. That I be the intelligent, amusing, somewhat eccentric older guy; that indeed, I be the trophy older guy.
That’s when it hit me. I could start a career as Emma Thompson’s trophy geezer, her partner in inspired, insane lunacy. She would have to pick up all the bills of course as whatever talents I posses have never led to money, but she can afford it. And to think, I have my wife to thank for this brilliant idea. My trophy geezer facebook page and twitter accounts should be going up soon as well as the trophygeezer.com website where you can sign up for courses on becoming a trophy geezer and share you experiences on the various trophy geezer forums. And I owe it all to Hepatitis C…
Disclaimer: The events, ideas and descriptions described in the above post may have occurred due to the interactions among the panoply of drugs I am currently taking in my treatment…
Sunday, July 18, 2010
Since We Were Talking About Side Effects…
The past four or five days have seen another shift in the nature of the side effects associated with treatment. Generally, I have noticed that the side effects I am experiencing are consistent for an extended period of time. The cycle of flu-like symptoms, fatigue and nausea has consistently started about 14-18 hours after the interferon injection and lasts about 36 hours. The fatigue also continues to moderate through the week after the interferon injection and my best days are usually Wednesday and Thursday, just before my next injection. The headaches and dyspepsia (which they define as an overly full feeling and general stomach discomfort) are intermittent but they happen for a few days each weekly cycle. This experience of side effects has been the same for about 10 weeks. This week saw changes in some of the effects and the resurfacing of one that had disappeared 10 weeks ago.
The last 5 days I have been mildly nauseous for most of my waking hours. This has also been accompanied by a bloated feeling in my stomach. I also had a return of dysgeusia (a change in the taste of food) as well. The nausea didn’t seem like much of an issue to me, although it did keep me from doing some of the things I was planning. I wasn’t running to the bathroom to vomit, I only had to lie down a couple of times and mostly I could ignore it or wait it out. Then I woke up this morning without it and realized how good it felt to just feel normal. There is nothing like suddenly not feeling a side effect to make you realize just how crappy it had been making you feel. I may have been tired all day today but damn, I felt good!
I have also had yet another change in the taste of food. The last one came about the time I started taking antidepressants and resulted in ice cream suddenly tasting good again. This time I have become extremely sensitive to things that taste sweet. I tried to eat a piece of chocolate on Thursday (yes, I shouldn’t be eating chocolate, see here, but I am weak) and it was so sweet I couldn’t finish it. Ice cream has once again become something I just can’t face eating as well as things like fruit preserves. I realized how extreme it had become just this evening. I had bought some sweet corn (25 cents an ear) and after boiling it up to have with sausage and potato salad, I could barely finish eating it as it seemed to be sickeningly sweet. Sweet corn, along with tomatoes, one of the iconic tastes of summer, what is Hep C treatment turning my body into?
I am now injecting 3 drugs per week, interferon, Procrit and Neupogen, so that might have something to do with the change in side effects. It might just be long-term sensitization to the drugs. It could be the changes in white and red blood levels or the interaction of the 7 daily and weekly drugs I am now taking, who knows. It seems my body is reaching a new rapprochement with the drugs I am taking and that it might mean a new cycle of side effects to get used to. It could be worse, the next time it might be grilled sausage that starts to taste like cardboard, anything but that…
The last 5 days I have been mildly nauseous for most of my waking hours. This has also been accompanied by a bloated feeling in my stomach. I also had a return of dysgeusia (a change in the taste of food) as well. The nausea didn’t seem like much of an issue to me, although it did keep me from doing some of the things I was planning. I wasn’t running to the bathroom to vomit, I only had to lie down a couple of times and mostly I could ignore it or wait it out. Then I woke up this morning without it and realized how good it felt to just feel normal. There is nothing like suddenly not feeling a side effect to make you realize just how crappy it had been making you feel. I may have been tired all day today but damn, I felt good!
I have also had yet another change in the taste of food. The last one came about the time I started taking antidepressants and resulted in ice cream suddenly tasting good again. This time I have become extremely sensitive to things that taste sweet. I tried to eat a piece of chocolate on Thursday (yes, I shouldn’t be eating chocolate, see here, but I am weak) and it was so sweet I couldn’t finish it. Ice cream has once again become something I just can’t face eating as well as things like fruit preserves. I realized how extreme it had become just this evening. I had bought some sweet corn (25 cents an ear) and after boiling it up to have with sausage and potato salad, I could barely finish eating it as it seemed to be sickeningly sweet. Sweet corn, along with tomatoes, one of the iconic tastes of summer, what is Hep C treatment turning my body into?
I am now injecting 3 drugs per week, interferon, Procrit and Neupogen, so that might have something to do with the change in side effects. It might just be long-term sensitization to the drugs. It could be the changes in white and red blood levels or the interaction of the 7 daily and weekly drugs I am now taking, who knows. It seems my body is reaching a new rapprochement with the drugs I am taking and that it might mean a new cycle of side effects to get used to. It could be worse, the next time it might be grilled sausage that starts to taste like cardboard, anything but that…
Saturday, July 10, 2010
Treatment Update - 5 weeks along in Standard Therapy
My latest viral load test results came back and I have a viral load of just a hair over 5,000 I.U./ml. That is a 3.76 log reduction from the 12,900,00 I registered at the beginning of treatment 29 weeks ago. It also shows a trend in the right direction following the viral breakthrough. My numbers from week 24 going forward are 17,000; 40,000; 10,000 and now 5,000. While the 5,000 number is not yet a truly significant reduction from the peak of my breakthrough viral load, it is getting awfully close.
Two other numbers are showing some change as well. My hemoglobin has dropped to 8.2 from the 11.4 it had climbed to after they reduced my Ribavirin dose to 1000 mg. during the final 6 weeks I was in the research study. My neutrophil count has dropped to 500 in the five weeks since they reinstituted a full dose of interferon. The response to these test results by my hepatologist illustrates clearly the difference in being treated outside of a research study. As I discussed in this post, the researchers running the study need to control, as thoroughly as they possibly can, the drugs that are utilized in the study. One of the primary goals of studies like this, after they determine the drug is effective against the virus, is to determine the side effects and potential dangers of the drug. They know the side effects of the standard of care and by adding only the new drug to the treatment, they can see if it amplifies or minimizes or introduces completely new side effects to the standard treatment. So when presented with test results that show that the research subject has anemia or low neutrophil counts they adjust the doses of the standard of care drugs or the research drugs to determine whether this is what is causing the problems. Unfortunately this can result, as in my case, in reducing the effectiveness of the treatment.
Now that I am being treated outside the research study in the standard of care therapy, they have a panoply of treatments they can use to address the problems and keep me on the full doses of the anti-viral drugs. In my case, the hemoglobin count went down fairly quickly and they put me on folic acid to attempt to build up my red blood cells. When that did not have much effect after about 10 days of taking it and my hemoglobin continued to fall, they prescribed procrit, a drug that directly stimulates red blood cell production. It is a drug that has to be injected once a week under the skin, like the interferon. In doing this for the first time, I tried to inject it into a pinched-up roll of fat on the right side of my belly area and discovered that the skin in that part of my body is like rubber. After trying three times to push the needle through this highly resilient and puncture-resistant patch of skin, I gave up and tried my left side. On that side it went right in and the injection was no problem. I’m thinking of offering the skin on the right side of my spare tire as a new material for bicycle tires. Spare tire tires; alligator skin tires; super skin tires; there has to be some money in selling skin outside the skin industry.
They are also attacking the low neutrophil count by prescribing neupogen another injectable drug that stimulates white blood cell production. I am currently in the process of urgent insurance authorization for that drug and should start using it next week. My wife thinks all this is turning me into a pincushion, as I will now be injecting three different drugs every week. I am also taking levothyroxine to stabilize my thyroid function. The change in thyroid function is also a side effect of the interferon. Luckily, this drug is in pill form and I take it once a day. The three drugs mentioned here are all being taken to enable me to continue taking full doses of interferon and Ribavirin to combat the Hepatitis C virus.
So the drug roster being taken either weekly or daily to fight the Hep C or the side effects of the drugs is:
Pegylated Interferon
Ribavirin
Procrit
Neupogen
Levothyroxine
Celexa
Trazadone
Tramadol
Ativan
The final numbers are not in yet as my nurse AR is working to find the cheapest drugs with the lowest copays but so far it works out to be a bit over $375 per month in copayments. This may go up or down some but if it holds at that number it is about $4500 for the duration of the treatment, assuming no additional drugs are needed.
Considering the only drugs I ever really took up until this time were the occasional course of antibiotics; painkillers after surgery or some muscle relaxants after throwing my back out, this level of involvement with the pharmaceutical industry is a whole new world…
Two other numbers are showing some change as well. My hemoglobin has dropped to 8.2 from the 11.4 it had climbed to after they reduced my Ribavirin dose to 1000 mg. during the final 6 weeks I was in the research study. My neutrophil count has dropped to 500 in the five weeks since they reinstituted a full dose of interferon. The response to these test results by my hepatologist illustrates clearly the difference in being treated outside of a research study. As I discussed in this post, the researchers running the study need to control, as thoroughly as they possibly can, the drugs that are utilized in the study. One of the primary goals of studies like this, after they determine the drug is effective against the virus, is to determine the side effects and potential dangers of the drug. They know the side effects of the standard of care and by adding only the new drug to the treatment, they can see if it amplifies or minimizes or introduces completely new side effects to the standard treatment. So when presented with test results that show that the research subject has anemia or low neutrophil counts they adjust the doses of the standard of care drugs or the research drugs to determine whether this is what is causing the problems. Unfortunately this can result, as in my case, in reducing the effectiveness of the treatment.
Now that I am being treated outside the research study in the standard of care therapy, they have a panoply of treatments they can use to address the problems and keep me on the full doses of the anti-viral drugs. In my case, the hemoglobin count went down fairly quickly and they put me on folic acid to attempt to build up my red blood cells. When that did not have much effect after about 10 days of taking it and my hemoglobin continued to fall, they prescribed procrit, a drug that directly stimulates red blood cell production. It is a drug that has to be injected once a week under the skin, like the interferon. In doing this for the first time, I tried to inject it into a pinched-up roll of fat on the right side of my belly area and discovered that the skin in that part of my body is like rubber. After trying three times to push the needle through this highly resilient and puncture-resistant patch of skin, I gave up and tried my left side. On that side it went right in and the injection was no problem. I’m thinking of offering the skin on the right side of my spare tire as a new material for bicycle tires. Spare tire tires; alligator skin tires; super skin tires; there has to be some money in selling skin outside the skin industry.
They are also attacking the low neutrophil count by prescribing neupogen another injectable drug that stimulates white blood cell production. I am currently in the process of urgent insurance authorization for that drug and should start using it next week. My wife thinks all this is turning me into a pincushion, as I will now be injecting three different drugs every week. I am also taking levothyroxine to stabilize my thyroid function. The change in thyroid function is also a side effect of the interferon. Luckily, this drug is in pill form and I take it once a day. The three drugs mentioned here are all being taken to enable me to continue taking full doses of interferon and Ribavirin to combat the Hepatitis C virus.
So the drug roster being taken either weekly or daily to fight the Hep C or the side effects of the drugs is:
Pegylated Interferon
Ribavirin
Procrit
Neupogen
Levothyroxine
Celexa
Trazadone
Tramadol
Ativan
The final numbers are not in yet as my nurse AR is working to find the cheapest drugs with the lowest copays but so far it works out to be a bit over $375 per month in copayments. This may go up or down some but if it holds at that number it is about $4500 for the duration of the treatment, assuming no additional drugs are needed.
Considering the only drugs I ever really took up until this time were the occasional course of antibiotics; painkillers after surgery or some muscle relaxants after throwing my back out, this level of involvement with the pharmaceutical industry is a whole new world…
Friday, May 28, 2010
Research Leverage – Use It or Lose It
In the previous post, I discussed at some length the reasons Research Drug Trials are often harder on the patient than Standard of Care (SOC) treatment through you doctor. I also talked about the advantages of being in a research trial not the least of which is the access to new drugs that can increase the chances for successful treatment. There is another aspect of being in a research trial that you can use to help you mitigate the side effects and stress of being in a drug trial, it is the leverage you have regarding the data they are collecting from you body.
Once they move beyond the Phase 1 trials to determine basic efficacy and safety, research trials increase in size and length. The reason is that to determine the effectiveness and side effects of the drugs under study, they need a large enough sample to give them statistical significance. Therefore they recruit hundreds of subjects for the trials. There is another reason for recruiting larger numbers of subjects. The researchers know that a certain number of the patients entering their trial will not finish it. Some will fail to abide by the parameters of the study. Others will consistently miss taking doses of their drugs and be dropped from the study. Still others will have such severe reactions to the drugs that they will not be allowed to continue. There are those who will leave the area and not be moving to a location that has the necessary facilities to allow them to continue and some will just not be able to stay the course for the necessary time to complete the study. So they need to recruit enough people to collect enough data even after the inevitable attrition of subjects.
This is where your leverage comes in. The researchers want your data, they need your data and they need you to complete the trial for that data to become a useful part of their records, reports and papers. Therefore they will go to some lengths to keep you in the study. If you move, they will try to find a lab or medical facility near you that can continue the testing they need for the trial. They will work hard to educate you about what you have to do as far as dosing and record keeping and keep at you to do it correctly. They will also prescribe remedies for some of the side effects to make it possible for you to stay in the trial.
That is why it is important to report side effects to the researchers as they happen. It is also important to tell them how severe they are. If they are interfering with your ability to function effectively tell the researchers that as well. For some of the side effects, they will adjust you research drug dose to attempt to mitigate the situation, for others they will prescribe medications to ease the side effects. It is not necessary to exaggerate any of the information you are giving them. Be factual, but above all be timely. If you report accurately and quickly when you have side effects and when those side effects are becoming a real detriment to your life, they will do what they can to help because they want your data. To get your data, they need you in the study. That is your leverage and if you don’t use it, you lose the advantages it can bring.
To use my case as an example, if I had reported the muscle pain in my sides that the interferon causes as soon as it happened, they would have prescribed Tramadol sooner. I would have been more comfortable and probably better rested earlier in the study than I was simply by reporting the severity of the situation as soon as it was happening. Likewise with the insomnia that is a common side effect. I was sleeping badly for a few weeks before the truly enormous bags and dark circles under my eyes made it plain that I was not getting enough sleep. When it became obvious they moved quickly to prescribe the Trazadone to help me sleep. The same was true with the depression caused by the interferon. If I had been reporting my mental state more accurately, it would have been apparently several weeks earlier that I need help for my mental state. As soon as it was plain that I did, they started on the search for the correct antidepressant.
So even though, they want to watch the progression and severity of the effects and side effects of the drugs and they want to control the variables of drug interactions by keeping what you are taking to a minimum, they also want you to complete the study and get your data. Use that leverage to help make your own treatment as bearable as possible.
Once they move beyond the Phase 1 trials to determine basic efficacy and safety, research trials increase in size and length. The reason is that to determine the effectiveness and side effects of the drugs under study, they need a large enough sample to give them statistical significance. Therefore they recruit hundreds of subjects for the trials. There is another reason for recruiting larger numbers of subjects. The researchers know that a certain number of the patients entering their trial will not finish it. Some will fail to abide by the parameters of the study. Others will consistently miss taking doses of their drugs and be dropped from the study. Still others will have such severe reactions to the drugs that they will not be allowed to continue. There are those who will leave the area and not be moving to a location that has the necessary facilities to allow them to continue and some will just not be able to stay the course for the necessary time to complete the study. So they need to recruit enough people to collect enough data even after the inevitable attrition of subjects.
This is where your leverage comes in. The researchers want your data, they need your data and they need you to complete the trial for that data to become a useful part of their records, reports and papers. Therefore they will go to some lengths to keep you in the study. If you move, they will try to find a lab or medical facility near you that can continue the testing they need for the trial. They will work hard to educate you about what you have to do as far as dosing and record keeping and keep at you to do it correctly. They will also prescribe remedies for some of the side effects to make it possible for you to stay in the trial.
That is why it is important to report side effects to the researchers as they happen. It is also important to tell them how severe they are. If they are interfering with your ability to function effectively tell the researchers that as well. For some of the side effects, they will adjust you research drug dose to attempt to mitigate the situation, for others they will prescribe medications to ease the side effects. It is not necessary to exaggerate any of the information you are giving them. Be factual, but above all be timely. If you report accurately and quickly when you have side effects and when those side effects are becoming a real detriment to your life, they will do what they can to help because they want your data. To get your data, they need you in the study. That is your leverage and if you don’t use it, you lose the advantages it can bring.
To use my case as an example, if I had reported the muscle pain in my sides that the interferon causes as soon as it happened, they would have prescribed Tramadol sooner. I would have been more comfortable and probably better rested earlier in the study than I was simply by reporting the severity of the situation as soon as it was happening. Likewise with the insomnia that is a common side effect. I was sleeping badly for a few weeks before the truly enormous bags and dark circles under my eyes made it plain that I was not getting enough sleep. When it became obvious they moved quickly to prescribe the Trazadone to help me sleep. The same was true with the depression caused by the interferon. If I had been reporting my mental state more accurately, it would have been apparently several weeks earlier that I need help for my mental state. As soon as it was plain that I did, they started on the search for the correct antidepressant.
So even though, they want to watch the progression and severity of the effects and side effects of the drugs and they want to control the variables of drug interactions by keeping what you are taking to a minimum, they also want you to complete the study and get your data. Use that leverage to help make your own treatment as bearable as possible.
Wednesday, May 26, 2010
Why Research Trials put the P in Pain, the F in Fatigue and the M in Mental Breakdown.
The pitfall of participating in a research drug trial for Hepatitis C is that it will tax your mind and body more harshly than if you underwent the standard treatment or Standard of Care. The upside of participating in the trial is that you get a chance to take a drug that improves (sometimes drastically) you chance of clearing the virus. In order to do the research necessary and gather the data needed for the study, the subjects of the research are required to enter the study “naked” or without the support of drugs and supplements that can help mitigate the side effects of the anti-Hep C medications, at least until the study doctors decide to administer any such mitigating therapies. (The word “naked” refers to a baseball term reported by Hall of Famer Tony Gwynn of the San Diego Padres. He stated that during his time in the Major Leagues players who took the field without using amphetamines were said to be “playing naked”).
What this means in practical terms is that the subjects of a research study will experience all the side effects of the anti-Hep C medications without the benefits of many of the established remedies that patients who undergo the Standard of Care of Pegylated Interferon and Ribavirin can take advantage of from the very beginning of the study.
Pegylated Interferon is well known to cause depression, fatigue, brain fog, nausea, insomnia and depressed white blood cell counts. Patients undergoing SOC through their doctors are often prescribed antidepressants before the start of the study in order to combat the depression. They are routinely prescribed anti-nausea medications and sleep aids from very early in their treatment to deal with those particular side effects as well. Ribavirin is well known to cause anemia (often severe), itchy rash, nausea and muscle pain. SOC patients are prescribed drugs to combat the anemia, given anti-itch creams (often with steroids), anti-nausea meds and painkillers for muscle and joint pain. These are usually given as the symptoms are reported and continue for the length of the treatment. This is not exactly the case with the subjects of a research study and there are very good reasons for that.
As I discussed in this post, the effectiveness of the Hep C drugs and the results of drug interactions are complex things to parse. Combine that with trying to track the side effects caused by the study drugs and you need to control as many of the variables as you can for an effective study. To that end during the screening process for the study, the study doctors want to know every drug and supplement you are taking. If any of them would interfere with their ability to determine the effects of the study medications, they will ask you to stop taking them or, if you cannot stop taking them for medical or other reasons, they may disqualify you from participating.
The same need for a controlled medical environment applies once the study begins. The researchers need to track the efficacy of the treatment drugs and the number and severity of the side effects. To do this, you need to experience the effect of the drugs and the side effects of the drugs without the interfering effects of other treatments and if there are other compounds you are taking, they need to be able to track their use.
So you are going to experience the side effects in full force. It is when the side effects are either dangerous or interfere with your ability to continue with the study that you may be prescribed something to help you deal with them. To use my case as an example, I have not and will not be prescribed anything to deal with the anemia caused by the Ribavirin. This is because they want to track as clearly as possible whether this new combination of drugs changes the instances and severity of the anemia. Many other individuals I have talked with about their treatment experience were given drugs to stimulate red blood cell production. Rather than do that the researchers have adjusted my Ribavirin dose to try to keep my hemoglobin count above the minimum they require to continue the trial. I have not been given anything to help with my white blood cell counts but have had my interferon dose adjusted and even skipped to attempt to keep my neutrophil and lymphocyte counts above the minimum to continue the trial. When I began to report muscle pain associated with treatment, I was told to take over the counter medications. It was only when I reported that the pain acute enough to interfere with my sleep, that I was prescribed a painkiller.
Interruption of your normal sleep patterns is one area that they respond to fairly rapidly. The researchers believe that getting enough sleep is vital to your ability to be able to complete the study. They want to hear if you are having difficulty sleeping and they want to be the ones to determine what remedy, be it over the counter or prescription you are going to take to combat the problem. It is a matter of controlling the variables again. In my case, about 6 weeks after the had prescribed the pain med Tramadol to deal with the pain that was keeping me awake I reported that I was having difficulty getting any more than 4-5 hours of sleep per night. They immediately prescribed Trazadone to help me sleep.
Depression is another major side effect that gets handled differently in a study. Unless a patient was already taking an antidepressant previous to screening for the study, they generally do not prescribe them until the researchers believe they are necessary to your ability to complete the study. Those of us undergoing the study in San Francisco were all given information on strategies to handle the stresses of the treatment and programs to give support to Hep C sufferers, but we were not prescribed anything for the condition until they were convinced we needed it. In my case it was about 18 weeks into the study before AVB began to believe I needed to be given something. By that time, it took me three weeks to gather my thoughts and energy enough to realize I was beginning to tip over into serious depression. At that point, they moved fast and started me on SSRI antidepressant drugs.
All these discussions and examples are provided to make sure you think about this aspect of a research study. I did not consider it at all. It was not until I had been in treatment for a few months that I went to a support group and talked to people who had undergone the standard treatment, that I found out that they were routinely prescribed things to deal with side effects. It was then that it hit me that as lab rats for Roche, we were going “naked” in the study. I have a bit of background in science and my wife has “A Masters Degree In Science,” as Doctor Science used to say. We both realize that controlling study variables is essential to getting good data and ending up with a useful study. I just didn’t think clearly at the beginning of the study, that I was the one whose variables were being controlled and that might mean the course of treatment might be a bit rougher than the SOC.
Knowing what I know now, I would not choose differently. In my mind, the chance to take a drug that increases my chances of clearing Hepatitis C genotype 1a by 50% is worth the potential of having a harder time in treatment. I wish I had thought it through and prepared myself mentally for the realities of what that would mean, but I would not change my decision.
Your decision is up to you. Think it through; be aware of what entering a research study means and then with the most forethought you can, make up your mind.
What this means in practical terms is that the subjects of a research study will experience all the side effects of the anti-Hep C medications without the benefits of many of the established remedies that patients who undergo the Standard of Care of Pegylated Interferon and Ribavirin can take advantage of from the very beginning of the study.
Pegylated Interferon is well known to cause depression, fatigue, brain fog, nausea, insomnia and depressed white blood cell counts. Patients undergoing SOC through their doctors are often prescribed antidepressants before the start of the study in order to combat the depression. They are routinely prescribed anti-nausea medications and sleep aids from very early in their treatment to deal with those particular side effects as well. Ribavirin is well known to cause anemia (often severe), itchy rash, nausea and muscle pain. SOC patients are prescribed drugs to combat the anemia, given anti-itch creams (often with steroids), anti-nausea meds and painkillers for muscle and joint pain. These are usually given as the symptoms are reported and continue for the length of the treatment. This is not exactly the case with the subjects of a research study and there are very good reasons for that.
As I discussed in this post, the effectiveness of the Hep C drugs and the results of drug interactions are complex things to parse. Combine that with trying to track the side effects caused by the study drugs and you need to control as many of the variables as you can for an effective study. To that end during the screening process for the study, the study doctors want to know every drug and supplement you are taking. If any of them would interfere with their ability to determine the effects of the study medications, they will ask you to stop taking them or, if you cannot stop taking them for medical or other reasons, they may disqualify you from participating.
The same need for a controlled medical environment applies once the study begins. The researchers need to track the efficacy of the treatment drugs and the number and severity of the side effects. To do this, you need to experience the effect of the drugs and the side effects of the drugs without the interfering effects of other treatments and if there are other compounds you are taking, they need to be able to track their use.
So you are going to experience the side effects in full force. It is when the side effects are either dangerous or interfere with your ability to continue with the study that you may be prescribed something to help you deal with them. To use my case as an example, I have not and will not be prescribed anything to deal with the anemia caused by the Ribavirin. This is because they want to track as clearly as possible whether this new combination of drugs changes the instances and severity of the anemia. Many other individuals I have talked with about their treatment experience were given drugs to stimulate red blood cell production. Rather than do that the researchers have adjusted my Ribavirin dose to try to keep my hemoglobin count above the minimum they require to continue the trial. I have not been given anything to help with my white blood cell counts but have had my interferon dose adjusted and even skipped to attempt to keep my neutrophil and lymphocyte counts above the minimum to continue the trial. When I began to report muscle pain associated with treatment, I was told to take over the counter medications. It was only when I reported that the pain acute enough to interfere with my sleep, that I was prescribed a painkiller.
Interruption of your normal sleep patterns is one area that they respond to fairly rapidly. The researchers believe that getting enough sleep is vital to your ability to be able to complete the study. They want to hear if you are having difficulty sleeping and they want to be the ones to determine what remedy, be it over the counter or prescription you are going to take to combat the problem. It is a matter of controlling the variables again. In my case, about 6 weeks after the had prescribed the pain med Tramadol to deal with the pain that was keeping me awake I reported that I was having difficulty getting any more than 4-5 hours of sleep per night. They immediately prescribed Trazadone to help me sleep.
Depression is another major side effect that gets handled differently in a study. Unless a patient was already taking an antidepressant previous to screening for the study, they generally do not prescribe them until the researchers believe they are necessary to your ability to complete the study. Those of us undergoing the study in San Francisco were all given information on strategies to handle the stresses of the treatment and programs to give support to Hep C sufferers, but we were not prescribed anything for the condition until they were convinced we needed it. In my case it was about 18 weeks into the study before AVB began to believe I needed to be given something. By that time, it took me three weeks to gather my thoughts and energy enough to realize I was beginning to tip over into serious depression. At that point, they moved fast and started me on SSRI antidepressant drugs.
All these discussions and examples are provided to make sure you think about this aspect of a research study. I did not consider it at all. It was not until I had been in treatment for a few months that I went to a support group and talked to people who had undergone the standard treatment, that I found out that they were routinely prescribed things to deal with side effects. It was then that it hit me that as lab rats for Roche, we were going “naked” in the study. I have a bit of background in science and my wife has “A Masters Degree In Science,” as Doctor Science used to say. We both realize that controlling study variables is essential to getting good data and ending up with a useful study. I just didn’t think clearly at the beginning of the study, that I was the one whose variables were being controlled and that might mean the course of treatment might be a bit rougher than the SOC.
Knowing what I know now, I would not choose differently. In my mind, the chance to take a drug that increases my chances of clearing Hepatitis C genotype 1a by 50% is worth the potential of having a harder time in treatment. I wish I had thought it through and prepared myself mentally for the realities of what that would mean, but I would not change my decision.
Your decision is up to you. Think it through; be aware of what entering a research study means and then with the most forethought you can, make up your mind.
Thursday, May 20, 2010
Complexity, Thy Name Is Drug Interactions
I do not envy medical researchers their jobs. While puzzling out the secrets of biochemical reactions and how they can be used to counteract the malign effects of viruses, bacteria, cancerous cells and the effects of defective genes must be fascinating and rewarding work, sorting out the effects and side effects seems dauntingly complex.
To use my case as an example, initially I was taking 3 drugs to attack the Hepatitis C virus. The interferon (Pegasys) and Ribavirin (Copegus) were well known drugs; indeed they are the Standard of Care or SOC, with well-documented effects and side effects. Those effects, however, all vary with the individual receiving treatment. For some, they have little effect on the Hep C virus, for others they are tremendously effective. Some individuals are devastated by the side effects, even to the point of being unable to complete the treatment, others individuals have a relatively straightforward time of it with a few difficult side effects but none that are debilitating. To this well-known set of circumstances they added a new drug, the polymerase inhibitor RO5024048 aka RG7128. Phase 1 testing had already been done using the new drug alone and its side effects noted, but aside from a worrying potential effect on the kidneys, many of the side effects mimicked those of the SOC. So as the study progresses and the effects and side effects are tracked and cataloged, it becomes vastly more complex to attempt to determine which drug might be doing what; what synergistic effects might be occurring between drugs; and what other effects might be the just the degree of effect of each drug on the specific individual undergoing treatment.
As the treatment progresses the Ribavirin wipes out your hemoglobin and gives you anemia and potentially itchy rashes. The interferon wipes out your white blood cells, saps your energy, fogs your brain, tends to give you depression and robs you of the ability to sleep well if at all. So to counteract these effects, additional drugs are prescribed. To continue the example of my case, I am currently taking 4 additional drugs. Firstly, I was given Tramadol (Ultram) to counteract the fact that as part of my interferon cycle, the muscles along the sides of my body can be achy and painful enough to leave me unable to lie down. As you might imagine this makes it difficult to sleep. Next, as the general insomnia caused by the interferon kicked in, I was given Trazadone to use as a sedative. Then, as the interferon gradually eroded my natural good cheer (okay my occasional good cheer) they prescribed an antidepressant, Paxil. In order to bridge the time it took for the Paxil to reach full effect, they added Ativan to the witches’ brew of drugs. The side effects of the Paxil necessitated a switch to another antidepressant, Celexa, but the total result is still the same. I am taking 4 additional drugs to counteract the effects of the drugs I am taking for the Hep C.
A final complication during the trial is changing dosing of drugs. In this trial, we only took the experimental polymerase inhibitor for either 8 or 12 weeks and potentially (depending on which arm of the trial you were in) at three different strengths. So after the first 12 weeks of the trial we were all down to 2 anti-Hep C drugs. There is also dose-adjusting going on for those two drugs as well. I have administered full, half and ¾ doses of interferon and even been told to skip a dose at various times during the study depending on my various white blood cell counts. I have been reduced to a lower level of Ribavirin to attempt to counteract my anemia. These sorts of adjustments are the norm for various patients throughout the course of the study.
To all this you can add the complicating effects of human foolishness, forgetfulness and folly (I should have written sports headlines). Again, we have the convenient example of my own case as an illustration. The context for this particular case of foolish forgetfulness comes from two previous posts. In one, I detailed all the benefits of The Everything Tastes Like Crap Diet, in the other I mentioned that chocolate had some very powerful effects on me after I started treatment. Well, the third day after I started the Paxil, while still in the speed rush phase of the acclimation period, I began to actually fell hungry again. I don’t know if it was the psychological effects of the Paxil or just because my body was using so many calories it was crying for food, but I went to the store with a real desire to buy food. I also noticed that foods I had not though appealing in weeks or months began to seem like they would be really good. The though of eating ice cream occurred to me for the first time in months, particularly chocolate ice cream. So I bought a pint of chocolate ice cream and went home and ate it in one sitting. The next day I did it again, and the next. All this time I was noticing that I was jittery and had a great deal of nervous energy. The jitteriness was moderating as the days went by (as I acclimated to the Paxil I thought), but did it occur to me that the effects of the massive doses of chocolate might be contributing to this? Heck no, never crossed my mind. By the way, despite the massive influx of delicious fat into my body, I still continued to lose weight.
Due to side effects that I believe are completely unrelated to any chocolate consumption (chocolate is supposed to increase libido, I believe), they switched me to Celexa. About 4 days in to the Celexa regimen, I once again noticed that I was a bit jittery and nervous. Finally it occurred to me that I had been eating a lot of chocolate. That same day, as I bought my pint of ice cream on the way home from work, I bought vanilla and have ever since. I haven’t noticed a huge difference, though I continue to be less jittery and nervous every day, but there is one more piece of evidence that I just can’t ignore.
I was at work today and I got a bit hungry around 11:00 a.m. I went down to the lunchroom and among the volunteer snax there was a bowl what I thought was trail mix but turned out to be pure M&Ms. I took a small cup of them went back up to my lair and proceeded to nibble on them as I prepped eBay auctions. About 15 minutes later I noticed I was a lot more wired than I had been before. It was not just a sugar rush, it was the jitters, case closed.
So, not only do the researchers have to deal with the seemingly endless complications of drug to disease interactions, drug to drug interactions and drug to human interactions, they also have the wild card of patients who can’t even keep track of their own food reactions. And these reactions are the ones the researchers are never even aware exist. Good luck to all of them, because we patients aren’t always reliable reporters.
I blame it all on the brain fog…
To use my case as an example, initially I was taking 3 drugs to attack the Hepatitis C virus. The interferon (Pegasys) and Ribavirin (Copegus) were well known drugs; indeed they are the Standard of Care or SOC, with well-documented effects and side effects. Those effects, however, all vary with the individual receiving treatment. For some, they have little effect on the Hep C virus, for others they are tremendously effective. Some individuals are devastated by the side effects, even to the point of being unable to complete the treatment, others individuals have a relatively straightforward time of it with a few difficult side effects but none that are debilitating. To this well-known set of circumstances they added a new drug, the polymerase inhibitor RO5024048 aka RG7128. Phase 1 testing had already been done using the new drug alone and its side effects noted, but aside from a worrying potential effect on the kidneys, many of the side effects mimicked those of the SOC. So as the study progresses and the effects and side effects are tracked and cataloged, it becomes vastly more complex to attempt to determine which drug might be doing what; what synergistic effects might be occurring between drugs; and what other effects might be the just the degree of effect of each drug on the specific individual undergoing treatment.
As the treatment progresses the Ribavirin wipes out your hemoglobin and gives you anemia and potentially itchy rashes. The interferon wipes out your white blood cells, saps your energy, fogs your brain, tends to give you depression and robs you of the ability to sleep well if at all. So to counteract these effects, additional drugs are prescribed. To continue the example of my case, I am currently taking 4 additional drugs. Firstly, I was given Tramadol (Ultram) to counteract the fact that as part of my interferon cycle, the muscles along the sides of my body can be achy and painful enough to leave me unable to lie down. As you might imagine this makes it difficult to sleep. Next, as the general insomnia caused by the interferon kicked in, I was given Trazadone to use as a sedative. Then, as the interferon gradually eroded my natural good cheer (okay my occasional good cheer) they prescribed an antidepressant, Paxil. In order to bridge the time it took for the Paxil to reach full effect, they added Ativan to the witches’ brew of drugs. The side effects of the Paxil necessitated a switch to another antidepressant, Celexa, but the total result is still the same. I am taking 4 additional drugs to counteract the effects of the drugs I am taking for the Hep C.
A final complication during the trial is changing dosing of drugs. In this trial, we only took the experimental polymerase inhibitor for either 8 or 12 weeks and potentially (depending on which arm of the trial you were in) at three different strengths. So after the first 12 weeks of the trial we were all down to 2 anti-Hep C drugs. There is also dose-adjusting going on for those two drugs as well. I have administered full, half and ¾ doses of interferon and even been told to skip a dose at various times during the study depending on my various white blood cell counts. I have been reduced to a lower level of Ribavirin to attempt to counteract my anemia. These sorts of adjustments are the norm for various patients throughout the course of the study.
To all this you can add the complicating effects of human foolishness, forgetfulness and folly (I should have written sports headlines). Again, we have the convenient example of my own case as an illustration. The context for this particular case of foolish forgetfulness comes from two previous posts. In one, I detailed all the benefits of The Everything Tastes Like Crap Diet, in the other I mentioned that chocolate had some very powerful effects on me after I started treatment. Well, the third day after I started the Paxil, while still in the speed rush phase of the acclimation period, I began to actually fell hungry again. I don’t know if it was the psychological effects of the Paxil or just because my body was using so many calories it was crying for food, but I went to the store with a real desire to buy food. I also noticed that foods I had not though appealing in weeks or months began to seem like they would be really good. The though of eating ice cream occurred to me for the first time in months, particularly chocolate ice cream. So I bought a pint of chocolate ice cream and went home and ate it in one sitting. The next day I did it again, and the next. All this time I was noticing that I was jittery and had a great deal of nervous energy. The jitteriness was moderating as the days went by (as I acclimated to the Paxil I thought), but did it occur to me that the effects of the massive doses of chocolate might be contributing to this? Heck no, never crossed my mind. By the way, despite the massive influx of delicious fat into my body, I still continued to lose weight.
Due to side effects that I believe are completely unrelated to any chocolate consumption (chocolate is supposed to increase libido, I believe), they switched me to Celexa. About 4 days in to the Celexa regimen, I once again noticed that I was a bit jittery and nervous. Finally it occurred to me that I had been eating a lot of chocolate. That same day, as I bought my pint of ice cream on the way home from work, I bought vanilla and have ever since. I haven’t noticed a huge difference, though I continue to be less jittery and nervous every day, but there is one more piece of evidence that I just can’t ignore.
I was at work today and I got a bit hungry around 11:00 a.m. I went down to the lunchroom and among the volunteer snax there was a bowl what I thought was trail mix but turned out to be pure M&Ms. I took a small cup of them went back up to my lair and proceeded to nibble on them as I prepped eBay auctions. About 15 minutes later I noticed I was a lot more wired than I had been before. It was not just a sugar rush, it was the jitters, case closed.
So, not only do the researchers have to deal with the seemingly endless complications of drug to disease interactions, drug to drug interactions and drug to human interactions, they also have the wild card of patients who can’t even keep track of their own food reactions. And these reactions are the ones the researchers are never even aware exist. Good luck to all of them, because we patients aren’t always reliable reporters.
I blame it all on the brain fog…
Tuesday, January 12, 2010
A Brief Note About Caffeine
The side effect that is most acute is the reaction of the meds with caffeine. I don’t know which one it is, whether it is the Interferon, the Ribavirin or the RG7128 aka RO5024048. What I do know is that I have had to cut my caffeine intake to near zero.
I was never a coffee drinker. It always made me jittery and I never liked the taste. I never like tea much either, the taste was not compelling. The caffeine I took in was all in the form of caffeinated sodas. Sometimes several of them a day. Then as I got older, I had to cut down to nothing caffeinated after about 2:30 in the afternoon, as I would be awake at nights if I had any later than that.
Several years ago, I trained myself into the habit of having a glass of green tea in the mornings at breakfast and that became my primary intake method, along with a soda or two during the day.
As soon as I started the study, I had to cut out all caffeinated sodas. If I had so much as a diet Dr. Pepper, I would get jittery and have the attention span of a gnat. Then I started to cut down the size of my Green Tea in the morning. If I had a full glass – about 10 ounces, I could definitely feel the effects and not in a pleasant and stimulating way. So, it was a small cup of tea in the mornings and then nothing the rest of the day. I still noticed some effects though, and realized that I was going to have to cut out chocolate as well.
Fine, the fatigue, itching, weakness, shortness of breath, irritability and insomnia were all things you can fight your way through, but NO CHOCOLATE, that’s just mean.
And I’m weak, so I am not going to get rid of it entirely, but I have cut way back. It all seems to be helping and I’m more calm and less irritable, but it is not something I read about in the discussions of either the Standard of Care treatment or the experimental drugs.
So be aware, it might help you a great deal to cut way down on your caffeine and anything that helps get through this is something to consider.
I was never a coffee drinker. It always made me jittery and I never liked the taste. I never like tea much either, the taste was not compelling. The caffeine I took in was all in the form of caffeinated sodas. Sometimes several of them a day. Then as I got older, I had to cut down to nothing caffeinated after about 2:30 in the afternoon, as I would be awake at nights if I had any later than that.
Several years ago, I trained myself into the habit of having a glass of green tea in the mornings at breakfast and that became my primary intake method, along with a soda or two during the day.
As soon as I started the study, I had to cut out all caffeinated sodas. If I had so much as a diet Dr. Pepper, I would get jittery and have the attention span of a gnat. Then I started to cut down the size of my Green Tea in the morning. If I had a full glass – about 10 ounces, I could definitely feel the effects and not in a pleasant and stimulating way. So, it was a small cup of tea in the mornings and then nothing the rest of the day. I still noticed some effects though, and realized that I was going to have to cut out chocolate as well.
Fine, the fatigue, itching, weakness, shortness of breath, irritability and insomnia were all things you can fight your way through, but NO CHOCOLATE, that’s just mean.
And I’m weak, so I am not going to get rid of it entirely, but I have cut way back. It all seems to be helping and I’m more calm and less irritable, but it is not something I read about in the discussions of either the Standard of Care treatment or the experimental drugs.
So be aware, it might help you a great deal to cut way down on your caffeine and anything that helps get through this is something to consider.
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