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…
Showing posts with label muscle pain. Show all posts
Showing posts with label muscle pain. Show all posts
Thursday, May 20, 2010
Monday, February 15, 2010
Was It The Chocolate?
Valentine’s Night was a lot more like Halloween night, pain angst and tossing and turning. We had a lovely Valentine’s evening, my wife and I. We exchanged gifts, had pizza – not necessarily what some would call a romantic dinner, but we didn’t have to make reservations, we had a cozy romantic setting at home and we could take our time without the spectre of the hovering waiter and the waiting fellow customers hoping we were going to finish up and leave soon.
Among our gifts were the requisite chocolates which we sampled liberally after our grilled chicken, mushroom and bell pepper pizza. We eventually retired later in the evening and after falling quickly asleep, I kept waking up all night long.
First it was aching and pain all along my left side. So I rolled over, fell asleep and woke up with pain all along my right side. After a bit of short dozing on either side was interrupted by the pain, I tried sleeping on my stomach. Fine for a while until my back locked up on me. After stretching that out, I tried sleeping on my back to avoid sleeping on either aching side. That worked for a few hours until I woke up with my back aching, my sides aching and my legs stiff.
I finally broke down and took 3 200 mg ibuprofens…and eventually fell asleep. I know that ibuprofen is not thought to be good for the liver, but I can’t imagine that sleep deprivation is any better for you. I have never had that level of pain and tenderness in my muscles since having some morphine during my last bout of diverticulitis. I have noticed that the last few injections of interferon have been increasing the level of muscle aches within the first few days of the injection. Maybe that was the case. Maybe it was the sugar or caffeine from the chocolate? I don’t know, but I am not looking forward to tonight if it is anything like last night.
Definitely no Chocolate tonight.
Among our gifts were the requisite chocolates which we sampled liberally after our grilled chicken, mushroom and bell pepper pizza. We eventually retired later in the evening and after falling quickly asleep, I kept waking up all night long.
First it was aching and pain all along my left side. So I rolled over, fell asleep and woke up with pain all along my right side. After a bit of short dozing on either side was interrupted by the pain, I tried sleeping on my stomach. Fine for a while until my back locked up on me. After stretching that out, I tried sleeping on my back to avoid sleeping on either aching side. That worked for a few hours until I woke up with my back aching, my sides aching and my legs stiff.
I finally broke down and took 3 200 mg ibuprofens…and eventually fell asleep. I know that ibuprofen is not thought to be good for the liver, but I can’t imagine that sleep deprivation is any better for you. I have never had that level of pain and tenderness in my muscles since having some morphine during my last bout of diverticulitis. I have noticed that the last few injections of interferon have been increasing the level of muscle aches within the first few days of the injection. Maybe that was the case. Maybe it was the sugar or caffeine from the chocolate? I don’t know, but I am not looking forward to tonight if it is anything like last night.
Definitely no Chocolate tonight.
Monday, January 4, 2010
Treatment: Lord Knows the Shape I’m In.
Started treatment this weekend.
There was a two hour appointment where they took the standard 14 vials of blood, 2 EKGs, Height, Weight, Temp, Blood Pressure and we got the skinny on what the procedures are for the trial. We are doing the Standard of Care (SOC) which is pegylated interferon and Ribivarin as well as the experimental drug or placebo. Of course we are all telling ourselves we are getting the new drug.
We were shown how to fill a syringe with the interferon and how to inject it, given 4 weeks worth of the various drugs and a set of syringes, alcohol wipes and band-aids – all in an attractive mini insulated fanny pack with a prominent Roche logo. Now if we could only get T-shirts and hoodies we could really be stylin’.
The interferon injection is pretty much the same as injecting insulin. It uses the same syringes and needles and the same technique of pinching up a bump of skin, sticking the needle and injecting the drug. It’s only 1 ml, so it’s not a lot and is quite painless at the time of the injection. We will be doing it once a week for the next 24 weeks at the minimum.
The Ribavirin and the RO5024048 are pills. 2 RO5024048 and 3 Ribavirin each morning and evening. With food or they say the nausea will be pretty intense.
We have to keep a diary noting the exact time each dose of the oral meds is taken and the day we inject the interferon. We have to keep all the bottles, vials, labels and syringes and show them to the researchers at every appointment. They count all the pills to make sure we have taken them and check the vial labels to see that we have injected. If we do not keep an accurate diary, we get one chance to make a mistake and at the second mistake or missing data or missed dose of the meds, we are bounced from the trial. (Now I’m not one to encourage the wrong sort of behavior, but if you knew that you were in a trial for a promising drug that ups the cure rate for your disease and you missed a dose, would you report missing a second dose? Or would you just throw the pills out, write something in the diary and never say a word? Human nature is a strange and wonderful thing…).
We were also given information on the common side effects and some techniques to mitigate them. The interferon can be pretty nasty to many people with flu-like symptoms, muscle aches, fever and nausea. It also suppresses the white blood cell production in your bone marrow making you more susceptible to infection during treatment. The Ribavirin will make you anemic over time and also has fatigue and (delightful combination this) insomnia as common side effects – and let’s not forget hair loss, also common. The RO5024048 has some similar side effects but the ones they are really worried about are kidney damage and problems with the eyes.
Did the first injection at the appointment and took the first 5 pills. We were told on a two separate occasions to make sure to bring 2 Tylenol to take before the injection, some food to eat (some sort of snack) to settle the stomach and a urine sample. The other guy who was in the training session with me forgot both Tylenol and food – I hope he remembered the urine but…
Went home and hung around waiting for the side effects shoe to drop. And waited and waited. Eventually I noticed that my neck and shoulders hurt and I was a bit chilled but only a touch of nausea as long as I was stretched out. As soon as I went to bed and slept in my usual side-sleeping fetal position, the nausea hit and I had to straighten out my body. It was a strange feeling to start to go into my normal position, feel really crappy, straighten my legs out and feel it subside. If you were really perverse, you could give yourself waves of nausea at will.
Over the next two days, I had some mild nausea, heartburn whenever I ate anything with any heft to it, and mild muscle aches. Not bad at all compared to the horror stories I had been hearing from people who had done the treatment and from what I read on treatment websites and bulletin boards.
On Sunday night (the third day) the insomnia set in. I was up till 2:00 a.m. before I could sleep. It wasn’t the sort of insomnia I have had before, thoughts racing through my head, anxiety, or nervous energy from late-in-the-day caffeine; it was just lying there with my eyes closed, comfortable and tired without be able to sleep at all.
Needless to say, Monday was a long slow slog through my first day back at work.
There was a two hour appointment where they took the standard 14 vials of blood, 2 EKGs, Height, Weight, Temp, Blood Pressure and we got the skinny on what the procedures are for the trial. We are doing the Standard of Care (SOC) which is pegylated interferon and Ribivarin as well as the experimental drug or placebo. Of course we are all telling ourselves we are getting the new drug.
We were shown how to fill a syringe with the interferon and how to inject it, given 4 weeks worth of the various drugs and a set of syringes, alcohol wipes and band-aids – all in an attractive mini insulated fanny pack with a prominent Roche logo. Now if we could only get T-shirts and hoodies we could really be stylin’.
The interferon injection is pretty much the same as injecting insulin. It uses the same syringes and needles and the same technique of pinching up a bump of skin, sticking the needle and injecting the drug. It’s only 1 ml, so it’s not a lot and is quite painless at the time of the injection. We will be doing it once a week for the next 24 weeks at the minimum.
The Ribavirin and the RO5024048 are pills. 2 RO5024048 and 3 Ribavirin each morning and evening. With food or they say the nausea will be pretty intense.
We have to keep a diary noting the exact time each dose of the oral meds is taken and the day we inject the interferon. We have to keep all the bottles, vials, labels and syringes and show them to the researchers at every appointment. They count all the pills to make sure we have taken them and check the vial labels to see that we have injected. If we do not keep an accurate diary, we get one chance to make a mistake and at the second mistake or missing data or missed dose of the meds, we are bounced from the trial. (Now I’m not one to encourage the wrong sort of behavior, but if you knew that you were in a trial for a promising drug that ups the cure rate for your disease and you missed a dose, would you report missing a second dose? Or would you just throw the pills out, write something in the diary and never say a word? Human nature is a strange and wonderful thing…).
We were also given information on the common side effects and some techniques to mitigate them. The interferon can be pretty nasty to many people with flu-like symptoms, muscle aches, fever and nausea. It also suppresses the white blood cell production in your bone marrow making you more susceptible to infection during treatment. The Ribavirin will make you anemic over time and also has fatigue and (delightful combination this) insomnia as common side effects – and let’s not forget hair loss, also common. The RO5024048 has some similar side effects but the ones they are really worried about are kidney damage and problems with the eyes.
Did the first injection at the appointment and took the first 5 pills. We were told on a two separate occasions to make sure to bring 2 Tylenol to take before the injection, some food to eat (some sort of snack) to settle the stomach and a urine sample. The other guy who was in the training session with me forgot both Tylenol and food – I hope he remembered the urine but…
Went home and hung around waiting for the side effects shoe to drop. And waited and waited. Eventually I noticed that my neck and shoulders hurt and I was a bit chilled but only a touch of nausea as long as I was stretched out. As soon as I went to bed and slept in my usual side-sleeping fetal position, the nausea hit and I had to straighten out my body. It was a strange feeling to start to go into my normal position, feel really crappy, straighten my legs out and feel it subside. If you were really perverse, you could give yourself waves of nausea at will.
Over the next two days, I had some mild nausea, heartburn whenever I ate anything with any heft to it, and mild muscle aches. Not bad at all compared to the horror stories I had been hearing from people who had done the treatment and from what I read on treatment websites and bulletin boards.
On Sunday night (the third day) the insomnia set in. I was up till 2:00 a.m. before I could sleep. It wasn’t the sort of insomnia I have had before, thoughts racing through my head, anxiety, or nervous energy from late-in-the-day caffeine; it was just lying there with my eyes closed, comfortable and tired without be able to sleep at all.
Needless to say, Monday was a long slow slog through my first day back at work.
Subscribe to:
Posts (Atom)
Posts
