Hey, look! I finally got my meds right!
Well, mostly. The sinus meds are making my heart rate skyrocket, so they need some adjustment. But the rest of it is finally A-OK. Hurray!
Hey, look! I finally got my meds right!
Well, mostly. The sinus meds are making my heart rate skyrocket, so they need some adjustment. But the rest of it is finally A-OK. Hurray!
Hey, kids – it’s that time again!
“I pledge my commitment to the Blog for Mental Health 2014 Project. I will blog about mental health topics not only for myself, but for others. By displaying this badge, I show my pride, dedication, and acceptance for mental health. I use this to promote mental health education in the struggle to erase stigma.”
What to say? I’m feeling less crazy than ever, which is pretty awesome. It seems that a lot of my insanity was really “just” an endocrine disorder, which merely goes to show how incredibly complex our bodies are. Last year, I officially gave up the bipolar diagnosis, and Mr. Chickadee said, “I told you so” because he never really believed it anyway. Despite some tough times here and there, plus a nonstop battle with my health insurance company, I also graduated from DBT and lost over 30 pounds, so a lot of good stuff happened too. I started keeping a gratitude journal, which has helped me stay more focused on the many things I have to be thankful for — and there really are so many.
But the coming year is full of change and anxiety-inducing things like moving and starting a new job, except I don’t know which job or where we’ll be living in 6 months — just that everything we have come to call home is going to change. It’s scary and it’s really hard for me to handle this level of uncertainty, but I feel like I’m doing pretty well with it most of the time. I’m trying to make strategic choices from a long-term perspective and focus on being realistic about what I need to succeed, which might mean a lower-ranked, lower pressure job, and I’m certainly OK with that tradeoff.
I’m hoping that after interview season in January/February, I can start weaning off the Wellbutrin XL that I’ve been on since 2001. I worry that my long-term use of these meds might mean that my body can no longer produce the right chemicals properly by itself, but I have to try. If I don’t really need this $500+/month prescription, it would be great to get it out of my life and save it for the next time a serious depressive episode rolls around. Because I know that’s likely – my standing psychiatric diagnosis is, for now, Major Depressive Disorder, Recurrent.
I haven’t been depressed in awhile, though I still have bad patches of dysphoria in which it’s like someone flipped a switch in my head and turned off self-esteem, confidence, and general competence, while turning on doubt, obsessiveness, and pessimism. Happily, however, those episodes are now less severe, more predictable, and shorter. Apparently my body really does need the progesterone boost for my brain to keep working properly!
And now I’m going to do the best thing I can for my mental health – put myself to bed.
Aloha ‘oe, friends – but just for now!
As I discussed earlier this week and some time ago on Canvas, brand name and generic drugs simply aren’t the same, even with the same active ingredient. Switching to brand Wellbutrin XL and Adderall XR has made an enormous improvement in my ability to function. So the question I’m exploring today is, why?
Because the active ingredients that actually constitute the “medicine” are the same (by law, within 80%-120% of the original) today’s topic is the inactive ingredients. Therein lies the difference between brand name and generic medications. Don’t believe the lies perpetuated by the FDA and swallowed whole by everyone else under the sun: having the same concentration of the active ingredient does not an equivalent medication make, particularly for extended release medications.
I did a little research on the ingredients in Adderall XR and Wellbutrin XL to compare against the generics by manufacturer – notably, many manufacturers have multiple distributors for generics. I also looked up what some of the mysterious chemicals actually are, and then coded them by alarming qualities: allergens, carcinogens, animal products, restricted by some religions (beyond animal products), toxins and other health risks. It’s all online but the source material is a mess.
I am not an expert in pharmaceuticals, I was not exhaustive in my methods, and I do not guarantee that the data ore presentation thereof are error-free. I looked up the ingredients but not in depth, so other sources may list some ingredients as an irritant where I did not find such information. The data I assembled follows the discussion so that you can do your own research and draw your own conclusions.
The only notable property, given my lack of success in searching out more manufacturers, is the inclusion of several common allergens in the Actavis generic, particularly food dyes. That is probably due more to the fact that the capsule is blue than anything else, because there are not many natural blue coloring agents besides indigo – a similar list of food dyes is probably present for the brand drug’s blue capsules too. However, food dye allergies are one of the causes of ADHD-like behavior in children who do not have ADHD, and presumably some who do. One of the dyes isn’t even approved for use in food (D&C as opposed to FD&C) which suggests it’s kinda nasty.
Actavis also appears to have substituted corn starch for talc, which seems odd given the rising rate of corn allergies, but talc is a carcinogen and it seems as though most substances that fulfill the same purposes (largely to do with the manufacturing process, as far as I can tell) are similarly problematic. But really, do these ingredients behave the same way in my gastrointestinal tract?
I dug deeper with Wellbutrin XL and its generics, in part because of the long-overdue FDA investigation into Impax and Teva for manufacturing a non-bioequivalent drug. Bioequivalence means that the drug should release at about the same rate and concentration, despite having different inactive ingredients that affect the release of the drug. With a long and profitable history, bupropion HCl generics are numerous, as are variations between the ingredient lists.
With few exceptions, the generics have longer ingredient lists than the brand drugs; in fact, I counted up to 11 ingredients that were not present in the original, and total ingredient lists that were twice as long. This is usually not a good sign in processed foods, where extra ingredients often make up for various deficiencies, real or perceived. But even the shortest generic recipe, which I’ve taken, is a far cry from the name brand in terms of efficacy – at least for me.
As is also apparent with the color-coding, the generics have more potentially objectionable ingredients as well, and a wider variety of them. For example, Wellbutrin XL contains only one ingredient I could find obvious problems with – povidones – which are needed for its sustained release, and are an allergen for only a very small number of people.
Granted, most of the potentially carcinogenic, toxic, and allergenic ingredients in all of these drugs are consumed in such small quantities that the FDA “Generally Regarded as Safe” label applies in spirit as well as letter, and most of us will probably come to no harm. That doesn’t mean people should be fed carcinogenic ingredients if there are alternatives, and usually there are.
We do not all metabolize these drugs the same way either, and as the Teva Budeprion debacle demonstrated, “extended release” may be more or less extended, which can have serious ramifications in terms of therapeutic response. As most adults in consumer cultures have learned, a “generic” label means that sometimes you get exactly the same thing, sometimes you get an equivalent but different thing, and sometimes you get an equivalent-looking but inferior thing. The intention of all the FDA rules is that you get an equivalent but different thing, because in pharmaceuticals, a generic can’t be the same as the brand due to intellectual property laws.
It seems, however, that we may often be getting an equivalent-looking but inferior thing. Perhaps the brand drugs use more expensive or trickier to manage ingredients, or higher quality versions of the same ingredients. We’ve all noticed that the soda pop that uses cane sugar costs more than the soda that uses high fructose corn syrup, right? In fact, it might be considered a defining characteristic of premium sodas: they use cane sugar, not corn syrup. Cane sugar is harder to work with and more expensive than corn syrup, I’m willing to bet, but it also tastes better.
Back in the world of prescription drugs, maybe glyceryl dibehenate costs more than methacrylic acid or is harder to handle – I really don’t know, but none of the generics use it. Or perhaps it’s substantially more expensive but causes fewer side effects, so that when the generic manufacturers choose alternative formulations, what they’re really doing is trading off cost against side effects. Certain side effects can be directly attributed to the active ingredients in these medications, but the so-called inactive ingredients can also wreak havoc on your innards.
The brand drugs can’t be raced to market quite as quickly as a generic version thereof, and if they’re preparing for first-round approvals, why let something avoidable like allergens in the filler spoil those very expensive trials? If you know that you’re going to be the only game in town when a drug goes to market, you’re more motivated to ensure that your product doesn’t include easily-avoided ingredients like lactose, gluten, and corn, which absolutely will make a lot of people sick. Given how much money they charge for a new miracle drug, it behooves them to avoid creating a quandary for vegans or those who observe strict religious diets, for example, making the brand drugs the last haven for the extremely allergic or seriously devout. Even in small quantities, allergens and ethics matter.
Read your prescription labels, figure out the manufacturer, and for goodness’ sake, look up what’s in that pill – especially if you have food and/or chemical allergies.
Remember the old adage, you get what you pay for? I’m afraid that despite the official party line claims that generics and brand drugs are “the same” (in some parallel universe, maybe) it seems the saying is just as true with prescription medications as anything else. And just like you don’t always need a brand name product to get the job done, sometimes there’s something about the original product that outshines its knock-offs.
In what world do we expect dollar-store generic goods to be every bit as high quality as a “household name” label? The only reason we believe generic medications will work the same is that we’ve been told that drug efficacy is limited to the active ingredient. The evidence suggests quite convincingly that it’s not.
Also: I have organized the ingredient lists alphabetically to make them easier to read, and because I can’t tell if the order of ingredients is meaningful like it is on food labels. The likely function of some of the ingredients is described upon the first mention, but my explanations are best guesses based on limited web searching.
ADDERALL XR, 20 mg capsule, brand, manufactured by Shire or Barr:
DEXTROAMPHETAMINE-AMPHETAMINE SALTS, extended release, 20 mg, Global
Same as above, Actavis – color-coded as light blue, instead of the orange that all other manufacturers use for 20 mg caps
WELLBUTRIN XL, 150 mg or 300 mg (pills are identical except for volume), brand, manufactured/distributed by Valeant, BTA, Physicians Total Care, Physicians Partners, or Stat Rx
BUPROPION/BUDEPRION HCL XL extended release, manufactured by Actavis
Same by Watson
Same by Edgemont, marketed as “Forfive XL” – 450 mg (max dose)
Same by CMC CMO
Same by Mylan
Same by Wockhardt
Same by Anchen, distributed by American Health Packaging
Same by Anchen, distributed by Stat Rx
My psych nurse tells me that she sees the biggest difference between brand and generic medication performance with Wellbutrin, Adderall, and Lamictal. My insurance approved her DAW – dispense as written, i.e., brand name only – for Adderall XR, which I filled for the first time last week. 15 minutes after taking the first pill, when the gelcap dissolved and the drug hit my bloodstream, it felt like everything had changed.
A week later, I can still hardly believe the difference. It’s not just that my symptoms are better controlled, but it’s also the extended release. It’s a true extended release, just like with brand Wellbutrin XL, and 40mg of amphetamines (two 20mg doses about 5 hours apart) doesn’t wear off in under 8 hours anymore. It lasts until I go to bed!
For me, this is practically inconceivable and nothing short of miraculous. I’m half terrified that it’s a placebo effect and my brain will stop working again next week, but it isn’t the first time that switching to brand drugs made this degree of difference. I might be able to reduce dosage because the brand name drug is that much more effective.
I’m telling you, friends, it’s like a brain transplant. Everything is better. Maybe that’s just coincidence with respect to mood, but reducing ADD symptoms also reduces anxiety and depression, because when I am better able to filter out stimuli, I’m less stressed on a systemic level. When I’m less stressed, I’m less anxious and less depressed. I even sleep better when I’m on stimulants, because my brain can actually shut off more readily when I go to bed.
The two brand drugs I’m taking are technically the same drugs I took for a dozen years as generics before things got truly out of control, but the difference in how well I can function while taking them is night and day. I can hardly believe I’ve been cheated out of this much quality of life by cheap-ass insurers, but I’m glad I now know the difference.
Why have I been denied the drugs that would have allowed me to function? Insurance doesn’t permit even trying the brand medication if a generic is available. Why? Cost and the myth of generic equivalency. Quoting from my initial denial letter for Wellbutrin XL:
according to your benefit, when a brand name drug has an FDA approved generic equivalent available, you must have failure or severe intolerance to a trial of at least 4 weeks of the generic and a completed MedWatch form must be submitted to the FDA documenting such failure or intolerance.
In addition, for Wellbutrin XL, I had to have tried the generic and at least two other drugs approved to treat depression, all for at least 4 weeks each. Never mind that all other drugs approved to treat depression very predictably make me extremely ill in under two weeks and always will, thanks to genetics.
My drugs are far from the most expensive brand meds out there – I can’t believe how much Abilify costs – but they don’t come cheap, even though they’re among America’s Favorite Meds. Prescription pricing is unregulated in many states, which is why large chain stores can offer certain common generic drugs for free or extremely cheap. Retail price versus negotiated price – insurers broker deals with pharmacies for prices – also makes a difference to perceived costs. My calculations use the prices my insurer negotiates with Rite Aid for the specific generics.
Given the combination of my location, insurer, and pharmacy, the generic extended release dextroamphetamine-amphetamine salts costs $253.15 for 60 x 20mg caps, which is a lot for a generic. It’s also sort of understandable because the active ingredients, amphetamines, are controlled and have actually been in shortage in recent history. Brand Adderall XR is $437.67, a difference of $184.52 per month, or $2,214.24 per year.
Generic Bupropion HCl XL costs $23.48 per month for 30 x 300mg tabs, but brand Wellbutrin XL costs $326.99, a difference of $303.51 per month from list price, or $3,637.12 per year. Notably, generic buproprion HCl XL has been shown to be non-equivalent to the brand, at least for one manufacturer’s 150mg tablet – which does not inspire confidence in any generic formulation of the drug.
If I took generics, my drugs would cost $276.63 monthly, $3,319.56 annually. On the brand drugs, it costs $764.66 a month to keep me going, $9,175.92 annually. I may cost nearly three times as much to maintain on brand drugs, but my ability to function is also nearly tripled.
Restricting access to more effective meds based on cost is just plain foolish because spending the extra $5,900 each year actually saves a ballpark $32,000 of salary that is otherwise wasted. With the brand drugs, I can function adequately to work about 85% of the time, instead of about 30% of the time on generics. Anyone with half a brain can see that the return on investment is completely justified solely on an economic basis, before we even start discussing issues like “pain and suffering.”
So, naturally, I started wondering – what the hell can be making such a huge difference? It’s not the active ingredients because those are regulated, sort of. But my body is extremely sensitive and empirical evidence has clearly demonstrated that the arguments claiming the so-called sameness of brand and generic meds are bullshit.
I decided a little investigate journalism was in order and did some research. The results of my foray into the inactive ingredients in Adderall XR and Wellbutrin XL were eye-opening. I’ll be sharing my findings, analysis, and interpretation in Part Two later this week.
So, until I reveal my hand with the second part of this post, I’m curious to hear from you: have you ever had the experience of switching drug manufacturers, or switching from generic to brand medication, that yielded a night-and-day difference?
I told the reproductive endocrinologist about the heart palpitations and he waved them off. My Psych Nurse didn’t; she ordered an EKG, which came back with an abnormal result. I’ve been referred to a cardiologist, and just filling out the paperwork has been stressful enough to give me more palpitations.
There are a couple of obvious potential causes of heart palpitations. As the endo pointed out, caffeine and stress are possible triggers.
I don’t know what happened, but all of the sudden, everything makes my heart race and struggle. Adding Yaz was the only recent change to my meds, since it’s possible but farfetched to blame lamotrigine withdrawal alone for causing arrhythmia. The palpitations started about two weeks after I started Yaz, but took about 6 weeks to build up to the point where I was worried enough to mention it to the docs.
I worry that all the meds are worsening an existing but dormant problem, interacting with or potentiating other medications, or otherwise just plain hurting my heart. But Yaz definitely played some kind of role in this – the big clue, as with every med to which I’ve ever had adverse reactions, is that the side effects hit their max at peak blood serum level timing – in this case, 1-2 hours. So I would take my meds at 7 AM and by 8:30 I was having heart palpitations every few minutes, fairly intensely, fading off a little after nine.
But then on the days I took the placebos, there were hardly any heart palpitations at all. So after the abnormal EKG, I discontinued Yaz in hopes that things would return to normal like they seemed to with the placebo pills.
Well, not yet, anyway. It’s unquestionably better, but just a few days after stopping Yaz I was very anxious about making my flight connections and had heart palpitations like crazy, very clearly associated with the anxiety rather than the timing of taking meds.
This never used to happen except during panic attacks, but now it’s just coming up more often for lesser worries, and it’s almost enough to scare me into a panic attack by itself. Since then, even on days when I didn’t take my ADD meds, I’ve still had heart palpitations – not many, but still. Enough to notice and worry. Quite a lot more than before.
I’m a bit terrified of what will come of the appointment with the cardiologist. I’m genetically prone to coronary heart disease but I’m doing everything right in terms of eating properly, losing weight, and getting reasonable exercise. So why am I suddenly having heart palpitations? What the hell is really going on here? What kind of horrible new tests are they going to inflict on me now? And is this a temporary thing, or will I have to deal with a bum ticker moving forward?
Worry worry worry…
Note: I am on vacation this week and won’t be replying until I am not on vacation and can face the computer without shrinking back in horror.
I usually have one day a month that’s jam-packed with medical appointments, to the exclusion of all else, and that was Tuesday last. I started off at the dentist’s, where my mouth was judged ready for impressions and crafting of a Permanent Crown!
Next stop: Nurse Nycta for the monthly check-in and psych drugs. We reviewed all things and decided to reduce Lamictal again, this time to 50 mg, and in 2 weeks, 25mg. I felt pretty certain that mood symptoms are aligned with hormonal problems, which the mood stabilizer can’t touch. But she’s as concerned as I about some details the endocrinologist really hasn’t adequately verified, tested, or ruled out.
I mentioned recent heart palpitations; she immediately ordered an EKG, concerned about heart complications from Yaz. The next day, I noted down times when I felt my heart racing, and wouldn’t you know, the palpitations appeared and were most frequent during peak serum level timing, 1-2 hours after dosing. A couple days later, on the placebo pills – no heart palpitations. Can you see where this is going to go?
Nycta also ordered every blood test under the sun, including potassium (part of the heart risk equation), lipids, and all the stuff I really do need checked a couple times a year. Plus all the hormone levels, again.
Third stop: Hippie Dude. By then, I was mostly just worrying about the next appointment and fretting about how bad things had been the week before. I hardly remember what we discussed, other than feeling overwhelmed and anxious about what will happen next. Not the most productive session ever.
Fourth stop: the Reproductive Endocrinologist. The nurse asked me what brought me in, so I mentioned diagnostic questions, concern over lack of any relief, and next steps in treatment when Yaz inevitably fails. When I went in to the endo and tried to go through the same list, he shot me down on point after point. Endometriosis? No, doesn’t cause PMDD (I didn’t say it did) or cyclic symptoms (have you empirically verified the cyclic nature of my symptoms? No?) Perimenopause? No, my periods weren’t irregular before birth control pills and hormone levels appear normal enough to a cursory review (but no one has asked about other qualitative changes, e.g. to duration and flow.)
But nothing is improving, I said, and this is beyond unbearable. So he spent some time berating me for complaining after only 2 months, when I should expect to wait 4-6 months to stabilize on Yaz. It turns out that the only reasons he prescribed Yaz were because it’s FDA approved for PMDD (big fucking deal) and because it has only 4 days of placebos. So if fewer placebo days is what will stabilize things, then I should just skip the placebos, right? No, he says, take the damn placebos. WTF?!?
The next option, since I don’t want to try Lupron, is Danazol. I’m not going to get into the details of why those are scary options, but they are scary. Lupron and Danazol shut down the ovaries completely, so you can imagine the kinds of side effects that entails (chemical menopause, basically.)
OK, so I understand that I should give the Yaz another 2 months. But what about these heart palpitations? He tells me it’s caffeine. How is that possible, I asked, after just one cup of coffee in the morning, same as it’s been for years? That makes no sense. It’s all stress, he says, changing his tune. Again, while I’ve been pretty stressed recently, it’s hardly a change from the status quo. The only thing that has changed recently is Yaz, which is known to cause heart problems. On the drug information insert, you’re instructed to immediately get an EKG if you experience arrhythmia – but my Department Chair Reproductive Endocrinologist knows better than the people who got their pants sued off to ensure that the heart risk warning is included on the patient information sheet. Uh-huh.
During the entire 10 minute appointment, I felt belittled and insulted over and over. The nurse looked uncomfortable – as the doctor dressed me down, she wouldn’t look at me. The student/intern/white coat who was observing looked bored. I mean, the collective body language was just insane – it said, “you’re wasting our time, crazy woman” in no uncertain terms. I tried to stand up for myself and felt like an idiot for it because the doctor just insulted me further. So much for being assertive.
This is by-the-book treatment based on half-assed diagnostic work. I know it’s the standard treatment because I can read WebMD, and any other OB/GYN would also be able to follow the step-by-step algorithm to hormonal obliteration. Or better yet, an NP could do it, probably without being a jerk. The only reason to see a pompous expensive asshole of an endocrinologist is for greater expertise and more options for treating severe cases, and hopefully superior diagnostic expertise as well. FAIL.
So what comes next? Good question; that’s a post for another day. Suffice it to say, though, that this dead end is the end o’ the endo, as far as I’m concerned.