But irritability isn't a side effect of the drug!
June 4, 2012 11:50 PM Subscribe
How to best petition the FDA for a drug safety change? Specifically a relaxations of "safety" standards as relating to isoretinoids (e.g. Accutane, Claravis, etc.).
(If you're familiar with the drug and its social issues, feel free to skip to the ***)
Two months ago I was put on Claravis for skin issues (the acne wasn't awful but I hated other stuff about my skin).
Three different doctors have marveled at how quickly I've improved on the drug, and although I've experienced ALL of the annoying "common" and "not unusual" side-effects, I wish I'd been told about this drug sooner. One "side-effect" is increased irritability, and although I've definitely experienced this, as I felt an increased need to punch someone a month *before* I was put on the drug (when I found out about its regulations) I don't think it's the actual drug's problem.
Since the drug causes birth defects, the month before I was put on it, I had to pass a pregnancy test (negative). Then I get another pregnancy test each month I'm on it. Additionally I need to initially pledge that I AM using TWO forms of birth control, one of which must be invasive (like an IUD, tubal ligation, or high-level hormonal - you cannot simply promise to use a diaphragm and condoms, say). ADDITIONALLY to that each month I need to log on to the computer and answer ridiculously stupid questions - questions that are covered in middle school sex ex (wow - I'm glad you're asking me again whether any form of birth control is 100% effective [true or false!], because I may have forgotten from last month...or just general common sense!). If I don't answer these questions I cannot get my prescription. I need to give the pharmacist a special card - where they can look up my answer data - before I can get the drug. If I forget my card (which isn't even credit-card sized, ARG) I can't get my prescription. If I don't answer the questions and get my prescription in less than a week, I have to go get another pregnancy test (this is actually already a relaxation of the original policy - that women aren't simply booted but can get another test)
Anyway....as I've said before, I wonder how much "increased irritability" comes from the unnecessary hoops needed to jump through. This includes tangible issues - the additional time in the Dr's office watching the repetitive video about birth defects, the inability to get refills called in, the delays in being able to bring the prescription in (my dr. gave me my newest prescription Friday....but I had to wait all weekend for the pregnancy test to clear), having to log on and answer questions, as well as having to buy birth control pills each month (even if you are not having sex in a way that could possibly result in conception), which is much more expensive than any of my other prescriptions (and which I've found out I cannot even take....) There are also the intangible issues. I dislike that it is assumed that all women are having sex with men, and that they are doing so in an unprotected manner - and even if they normally do that they would continue this after being informed about birth defects, and THEN even after requiring a pledge still requiring a pregnancy test. Additionally, although what I've officially read on this is that men are simply not subjected to the pregnancy tests, a male friend on it told me he didn't have to do even half of this.
Minor irritations include that all this "don't get pregnant - don't get pregnant - OMG DON'T GET PREGNANT" overshadows ACTUAL, useful information on side-effects. I suffered extreme joint pain for an entire month without even realizing this was a potential side-effect (I thought I was just getting old, haha...well, when I saw my PCP I thought maybe lyme's too). Typically I read the entire "side-effects may include" pamphlet for any new drug, but this one's was so large and mainly consisted of "bad for babies, bad for babies, OMG SO BAD FOR BABIES".
Part of me says, "why bother - you're only on it for five months, and it's almost over", but part of me is just so offended that I'm being thoroughly inconvenienced on behalf of an imaginary fetus - to the extent that I'm "required" to take birth control, even if it makes me sick.
***
ANYWAY, so that's the background on isoretinoids and my reasons why I want to re-evaluate the "safety" concerns about them. I've seen the FDA's page on commenting on regulations, and so I'd like to submit something....but if anyone's done this, how much detail should I go into? Would there actually be any consideration if I simply wrote a letter stating my case? Would it be measurably better if I got Dermatologist and Pharmacist testimonials, or even surveyed patients (I wouldn't want to spend hours collecting this data if the FDA never really considers these comments....). If I were to try to include patient frustrations, how would I go about that? If a Dermatologist was sympathetic to the petition, would they be willing to contact past patients (I wouldn't ask for their info, but ask the Dr. to convey the info along)?
When I do my initial petition, would it make sense to offer an alternative? The FDA implemented this program when a previous program failed to work, but the previous program wasn't regulated in ANY way - some women weren't even told there was a chance of birth defects. It definitely needs regulation, but I don't think at this level..... It says they receive 200 petitions a year, which seems low to me, so I'm thinking it needs to be a thorough endeavor, so....any advice?
(If you're familiar with the drug and its social issues, feel free to skip to the ***)
Two months ago I was put on Claravis for skin issues (the acne wasn't awful but I hated other stuff about my skin).
Three different doctors have marveled at how quickly I've improved on the drug, and although I've experienced ALL of the annoying "common" and "not unusual" side-effects, I wish I'd been told about this drug sooner. One "side-effect" is increased irritability, and although I've definitely experienced this, as I felt an increased need to punch someone a month *before* I was put on the drug (when I found out about its regulations) I don't think it's the actual drug's problem.
Since the drug causes birth defects, the month before I was put on it, I had to pass a pregnancy test (negative). Then I get another pregnancy test each month I'm on it. Additionally I need to initially pledge that I AM using TWO forms of birth control, one of which must be invasive (like an IUD, tubal ligation, or high-level hormonal - you cannot simply promise to use a diaphragm and condoms, say). ADDITIONALLY to that each month I need to log on to the computer and answer ridiculously stupid questions - questions that are covered in middle school sex ex (wow - I'm glad you're asking me again whether any form of birth control is 100% effective [true or false!], because I may have forgotten from last month...or just general common sense!). If I don't answer these questions I cannot get my prescription. I need to give the pharmacist a special card - where they can look up my answer data - before I can get the drug. If I forget my card (which isn't even credit-card sized, ARG) I can't get my prescription. If I don't answer the questions and get my prescription in less than a week, I have to go get another pregnancy test (this is actually already a relaxation of the original policy - that women aren't simply booted but can get another test)
Anyway....as I've said before, I wonder how much "increased irritability" comes from the unnecessary hoops needed to jump through. This includes tangible issues - the additional time in the Dr's office watching the repetitive video about birth defects, the inability to get refills called in, the delays in being able to bring the prescription in (my dr. gave me my newest prescription Friday....but I had to wait all weekend for the pregnancy test to clear), having to log on and answer questions, as well as having to buy birth control pills each month (even if you are not having sex in a way that could possibly result in conception), which is much more expensive than any of my other prescriptions (and which I've found out I cannot even take....) There are also the intangible issues. I dislike that it is assumed that all women are having sex with men, and that they are doing so in an unprotected manner - and even if they normally do that they would continue this after being informed about birth defects, and THEN even after requiring a pledge still requiring a pregnancy test. Additionally, although what I've officially read on this is that men are simply not subjected to the pregnancy tests, a male friend on it told me he didn't have to do even half of this.
Minor irritations include that all this "don't get pregnant - don't get pregnant - OMG DON'T GET PREGNANT" overshadows ACTUAL, useful information on side-effects. I suffered extreme joint pain for an entire month without even realizing this was a potential side-effect (I thought I was just getting old, haha...well, when I saw my PCP I thought maybe lyme's too). Typically I read the entire "side-effects may include" pamphlet for any new drug, but this one's was so large and mainly consisted of "bad for babies, bad for babies, OMG SO BAD FOR BABIES".
Part of me says, "why bother - you're only on it for five months, and it's almost over", but part of me is just so offended that I'm being thoroughly inconvenienced on behalf of an imaginary fetus - to the extent that I'm "required" to take birth control, even if it makes me sick.
***
ANYWAY, so that's the background on isoretinoids and my reasons why I want to re-evaluate the "safety" concerns about them. I've seen the FDA's page on commenting on regulations, and so I'd like to submit something....but if anyone's done this, how much detail should I go into? Would there actually be any consideration if I simply wrote a letter stating my case? Would it be measurably better if I got Dermatologist and Pharmacist testimonials, or even surveyed patients (I wouldn't want to spend hours collecting this data if the FDA never really considers these comments....). If I were to try to include patient frustrations, how would I go about that? If a Dermatologist was sympathetic to the petition, would they be willing to contact past patients (I wouldn't ask for their info, but ask the Dr. to convey the info along)?
When I do my initial petition, would it make sense to offer an alternative? The FDA implemented this program when a previous program failed to work, but the previous program wasn't regulated in ANY way - some women weren't even told there was a chance of birth defects. It definitely needs regulation, but I don't think at this level..... It says they receive 200 petitions a year, which seems low to me, so I'm thinking it needs to be a thorough endeavor, so....any advice?
I'm peripherally involved in clinical research, but am not a doctor.
There's basically two ways you can get a change made here:
1) Find enough other patients using this drug and start an advocacy group to pressure the FDA into revising their labeling.
2) Find enough other patients using this drug and start an advocacy group to convince the drug manufacturer that's it's worth their time and money to go back to the FDA to try and get the label changed.
And, honestly, odin is right there, the legal liability for birth defects is so ridiculously high that I'm sure that drug company and the FDA are working hand in glove on this program, there will be virtually zero sunlight between the two of them.
posted by Oktober at 7:13 AM on June 5, 2012 [1 favorite]
There's basically two ways you can get a change made here:
1) Find enough other patients using this drug and start an advocacy group to pressure the FDA into revising their labeling.
2) Find enough other patients using this drug and start an advocacy group to convince the drug manufacturer that's it's worth their time and money to go back to the FDA to try and get the label changed.
And, honestly, odin is right there, the legal liability for birth defects is so ridiculously high that I'm sure that drug company and the FDA are working hand in glove on this program, there will be virtually zero sunlight between the two of them.
posted by Oktober at 7:13 AM on June 5, 2012 [1 favorite]
Response by poster: Oktober, the question was really HOW to go about doing that - HOW would I best get in contact with patients.
AGAIN, the question is NOT whether you think the program is good or not (especially considering that this program still sees birth defects cause irresponsible people gonna be irresponsible).
posted by Lt. Bunny Wigglesworth at 12:39 PM on June 5, 2012
AGAIN, the question is NOT whether you think the program is good or not (especially considering that this program still sees birth defects cause irresponsible people gonna be irresponsible).
posted by Lt. Bunny Wigglesworth at 12:39 PM on June 5, 2012
Oktober is right. If you want to make a difference, campaign and write to your congresspeople about medical malpractice reform. If liability wasn't such a crazy concern, the hoops to jump through related to this and many, many other medications/procedures/diagnostic protocols would not need to exist.
I don't think petitioning or anything else will help with the malpractice situation being what it is, because people are allowed to sue even when known risks, complications, or side effects occur. That means the only way to be safe from lawsuits is to eliminate risks (not usually possible). But if you still want to do this you can create your own petition at change.org .
posted by treehorn+bunny at 2:57 PM on June 5, 2012
I don't think petitioning or anything else will help with the malpractice situation being what it is, because people are allowed to sue even when known risks, complications, or side effects occur. That means the only way to be safe from lawsuits is to eliminate risks (not usually possible). But if you still want to do this you can create your own petition at change.org .
posted by treehorn+bunny at 2:57 PM on June 5, 2012
I was going to chime in with Change.org, but I got beat. If you do start a petition, I would love to add my name.
Just to give you a timeline for these regulations, I took Accutane in 2001 and I faced far fewer hoops. I did have to:
- pledge to the physician that I would use a passive and active BC in conjunction.
- look at little deformed fetuses on my pill packages everyday.
- provide monthly blood draws for pregnancy/liver function tests.
I am a huge fan of this drug and I think that it is really unfortunate that it has become so difficult to obtain.
posted by Vysharra at 6:18 PM on June 5, 2012
Just to give you a timeline for these regulations, I took Accutane in 2001 and I faced far fewer hoops. I did have to:
- pledge to the physician that I would use a passive and active BC in conjunction.
- look at little deformed fetuses on my pill packages everyday.
- provide monthly blood draws for pregnancy/liver function tests.
I am a huge fan of this drug and I think that it is really unfortunate that it has become so difficult to obtain.
posted by Vysharra at 6:18 PM on June 5, 2012
Anyway....as I've said before, I wonder how much "increased irritability" comes from the unnecessary hoops needed to jump through.
Uh, no, this is fucking insane. The calmest person in the world would eventually be seething over this.
But because of your description, I will count my blessings the next time I'm jumping through hoops to get my ADD meds. Thus counteracting my medication-related "increased irritability."
posted by desuetude at 8:16 PM on June 6, 2012
Uh, no, this is fucking insane. The calmest person in the world would eventually be seething over this.
But because of your description, I will count my blessings the next time I'm jumping through hoops to get my ADD meds. Thus counteracting my medication-related "increased irritability."
posted by desuetude at 8:16 PM on June 6, 2012
This thread is closed to new comments.
posted by jessamyn (staff) at 7:03 AM on June 5, 2012 [1 favorite]