there are differences
Medicated For Your Protection
Table of Contents (hide)
- 1. Introduction
- 2. What’s the difference?
- 3. A Dose by Any Other Name
- 4. Four Out of Five Doctors and Pharmacists Agree
- 5. How Much More Proof do You Need?
- 6. What Does the FDA Have to Say About it?
- 7. And it all Comes Down to…What?
One of the most debated issues in health care today concerns the difference between brand name (also called branded, innovator, and pioneered) drugs and their generic versions (usually called “equivalents”). While most everyone can agree generic drugs are less expensive than the branded versions,1 whether or not generics are always the same as brand is another question. “Different” doesn’t always mean “not as good.” In some cases a generic drug can be better than the branded version in more ways than just being significantly less expensive.
This page is about prescription, dosage-critical medications, mostly antiepileptic drugs (AEDs). When it comes to something you can buy at a bodega/corner store/convenience store like Aleve (naproxen sodium) or Advil (ibuprofen), you’d be an idiot not to get the generic2. Unless you’ve had a bad experience with the store brand of whatever store you find yourself in.
The party line answer from the FDA, the AMA,3 big pharma, and most pamphlets, books, TV commercials, and any other source of information is: generic drugs are exactly the same as brand name medications.
Reality is more complicated than that, especially in the world of crazy meds. Like so many things it depends on the drug, the condition being treated, and the person taking the medication. The odds are it won’t make much of a difference as far as you’re concerned. But if you do notice a change in how well your meds worked, side effects, or anything else after you were switched from a branded/brand-name medication to a generic, or from one generic to another (the pills look different, and/or the numbers changed), it’s not all in your head. Literally. In spite of these drugs usually targeting your brain, your brain has little, if anything, to do with any difference in effect when taking meds made by different manufacturers.
We’ve got a lot of terminology to cover.
We pretty much all know that “Generic” is the generic term for any drug made with an active ingredient that is no longer on patent and is no longer protected by FDA exclusivity4. Only a few crazy meds are almost always referred to by their generic names, like lithium and phenobarbital. “Generic” is both a noun and an adjective.
“Brand name” is complicated. “Brand name,” or “trade name,” are fairly straightforward. Unfortunately they are not universal. The term “branded” is also used, as is “brand.” You may even see terms like “pioneered drug,” “innovator’s product,” or “originator tablet,” but those aren’t used very often these days. Except for “innovator” drug/medicine/some other term, which is still used in research papers. “Brand” alone is confusing because many people use “brand” to refer to generics made by different manufacturers (e.g. “I never had any problems with Teva’s brand of lamotrigine…”), while “branded” is problematic because of the term “branded generic.”
“Branded generic” has three meanings:
- A generic drug produced by a generics manufacturer that is a wholly-owned subsidiary of the company that makes the branded version. E.g. Greenstone Pharmaceuticals makes gabapentin, and they are owned by Pfizer, who also own Parke-Davis, who bought Warner-Lambert, who pioneered Neurontin.
- A branded generic is also a generic drug given a ‘brand’ name by the manufacturer (e.g. Teva’s Budeprion), but otherwise has the same active ingredient as the original branded version (Wellbutrin).
- A branded generic is also a generic drug given a ‘brand’ name by the manufacturer and uses a salt of the active ingredient that is different from the original branded version and other generics. E.g. Sanofi-Aventis’ Aplenzin, which is bupropion hydrobromide, while Wellbutrin, Budeprion and most of the others are bupropion hydrochloride. The FDA says they’re the same thing, and, as usual, the data are contradictory.
In English: A generic drug is as safe, effective, and acts the same way as the brand name drug at the same dosage. I.e. it lives up to the promises that everyone makes about generic drugs.
Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
FDA classifies as therapeutically equivalent those products that meet the following general criteria: (1) they are approved as safe and effective; (2) they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Manufacturing Practice regulations. --the Orange Book 5
3.3 Bioequivalence (BE) & Bioavailability (BA)
Most of the therapeutic equivalence standards are essentially paperwork. The only things that requires any testing are bioequivalence (BE) and bioavailability (BA). These are the numbers with the allowed 80–125% variance everyone talks about. Like most people without any training6, I wrote that had to do with how well the active ingredient got absorbed and distributed, which would be its BA. At least I wasn’t as wrong as everyone who that that was how much of difference in the actual active ingredient a generic med could have in it. The 80–125% range actually refers to the confidence interval (CI) of different pharmacokinetic parameters (see below for those). In English: if you remember what you learned in statistics class I probably don’t need to explain it to you, which is a good thing, because years of poorly treated epilepsy and bipolar have fried the part of my brain that remembered and understood math more complicated than adding and subtracting anything larger than 3-digit numbers. As for the rest of us it means their math looks good when they show there’s not too much of a variance.
So BE essentially means the pharmacokinetics (PK) are fairly close, and with a CI of 80–125% the actual difference in BA shouldn’t be more than 5%. Sometimes that’s enough, and sometimes it’s way more than that in spite of passing the BE tests. Why?
First of all, whenever generics manufacturers run BE/PK testing on humans, they do one test on 24–36
professional guinea pigs “healthy volunteers” who are mostly white males between the ages of 18 and 55. The tests are always the same, one dose, often the lowest anyone would ever take, first thing in the morning on an empty stomach. It doesn’t matter if it’s a sleeping pill that works better (even to deal with side effects) when taken with a meal, it’s the same routine every time.
If they want to be really thorough - but not go so far as to have on group of patients taking the brand name med and another group taking their
placebo generic version - a generics manufacturer will do a crossover test. That’s where they’ll get two groups of professional guinea pigs healthy volunteers. One group will take a single dose of the generic and one group will take a dose of the brand, and the only PK values that seem to matter are measured. Then two or three weeks later each group gets the other med. In that way anyone who is a poor or rapid metabolizer of a drug won’t skew the numbers. The crossover test makes a lot of sense, with a single-dose test it’s meaningful only for medications with active metabolites like Trileptal and Risperdal, where the pill you take isn’t what works on your brain, your liver needs to transform it first.
The rest has to do with the complexities of PK…
Pile of Pills
Medicated For Your Protection
3.4 Pharmacokinetics (PK)
Pharmacokinetics (PK) is what your body does to a drug. It’s a geek’s paradise of hardcore technical data, full of data regarding how well a drug is absorbed and distributed, how long it takes to clear from your system, what potential drug-drug interactions there can be, and so forth. As far as BE goes, the FDA cares about two things: the maximum blood plasma concentration (C-max), and the plasma concentration time curve (AUC). If you look at Paxil’s PK, including most of the popular BA / BE parameters,7 there are a hell of a lot more data that can be used to nail down the theoretical difference in BA / BE, or to explain why an actual difference exists. Somehow the FDA thought those two were enough.
So with only those two parameters used, and only after a single, often sub-therapeutic, dose, it’s way too easy for a drug to appear equivalent when it’s not.
These all mean the same thing, which is two different things.
- First is what we’re discussing here - how the slightest change in a med’s dosage (how much you take), or dosing (when and how often you take it), is the difference between a med that works and a med that doesn’t work or has side effects that suddenly suck worse than the condition being treated. Lots of people who take Topamax or Lamictal know what a huge difference there can be between 375mg a day and 400mg a day of either. Lots of people who take Effexor or Keppra know that taking your pill a few hours late can sometimes lead to a world of hurt.
- Then there’s the original meaning - that there’s not much of a difference between an effective dosage and a toxic dosage.
I use dosage critical for the former and narrow therapeutic index (NTI) or margin for the latter. There aren’t very many crazy meds with an NTI. Lithium is one. For bipolar disorder a blood plasma test usually determines, or at least strongly influences your dosage. The therapeutic range is 0.6–1.2, but lithium toxicity can start at a level of 0.9.
This page, and the concept itself, has nothing to do with drugs that are not dosage-critical. I have no idea if the therapeutic margin is so narrow there can be a difference in efficacy between brand Viagra and generic sildenafil, but I find it highly unlikely there will be much of a difference in efficacy between brand Propecia and generic finasteride. Differences in side effects due to inactive ingredients are always a possibility regardless of the drug.
Actually it’s more like half of doctors and pharmacists surveyed say when dosage-critical drugs are involved, there can be a significant difference between brand-name and generic drugs, as well as between meds from different generics manufacturers. With doctors it tends to depend on their specialty. But more and more doctors from more and more specialties are getting behind the new party line:
- If their patient began treatment with a brand-name, dosage-critical drug, or drug with a narrow therapeutic index, then they should stay on the branded med.
- If their patient began treatment with a generic dosage-critical drug, or drug with a narrow therapeutic index, then generics are fine. And, if at all possible, they shouldn’t be switched from one manufacturer’s med to another’s without a good reason. E.g. an allergy to an inactive ingredient.
- Many individual prescribers and pharmacists are with us in that they know some manufacturers are churning out sub-standard products that no one should take, unless they should be taking a placebo. As far as I know no organized group has come out to call specific drug manufacturers on that, or to recommend the FDA do something about it, etc.
How do I know doctors & pharmacists are starting to come around?
- Roughly half of all neurologists have had a patient lose seizure control or some other new adverse reaction after switching from brand to generic.
- The 50% statistic also comes up in this paper.
- the Italian League against Epilepsy agrees with the policy of not switching between brand and generic, or between different generics manufacturers. They go one step further and don’t want to switch between immediate and extended release without a damn good reason.
- Pharmacists questioning use of generic AEDs?
- Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsy - no hard numbers in the abstract, just a lot of people think it’s a bad idea.
- American Academy of Neurology (AAN) is trying to ban automatic generic substitution of AEDs
- New York Times article on brand vs. generic meds
- L.A. Times article on the FDA’s standards for bioequivalence
- Denmark has tightened its standards. 80–125% CI isn’t good enough for some meds, and there can be no generic substitutions for others.
Nothing is ever cut & dry in pharmaceuticals.
- The price we pay for physician gullibility on generics. With a title like that…oh, it’s an HMO-sponsored publication. Still, the author raises the obvious point: there’s a hell of a lot more money to be made by Bigger Pharma (i.e. drug pioneers/innovators) pushing brand name drugs than Not-Quite-So-Big Pharma (companies that make nothing but generics) with big box stores selling $4 generics.
- A lot of people making noise about the problems with generic meds, like the Epilepsy Foundation, get a shitload of money from Bigger Pharma.
Once again, don’t just take my word for it.
- Switching from brand AEDs to generic is just not a good idea.
- Switching to generic = trip to the ER. This study found that epileptics who were taking A-rated (AKA the good stuff) meds and had to go to the ER were 81% more likely to have been switched to a generic.
- Here’s one survey of people forced to switch to generic where 13% of those taking lamotrigine had to switch back to Lamictal.
- And here’s another where 27.5% switched back to brand Lamictal, 20.8% to 44.1% switched back for various other AEDs.
- No surprise: switching from brand Dilantin resulted in more seizures. The steady state blood plasma concentrations were significantly different. You know, what you’d have after taking your medicine for a week or so, and not just one day.
- Here’s another Dilantin vs. generic phenytoin. This is exactly the sort of double-blind, brand vs. generic test I think should be done. Oh, wait, people could lose seizure control and prove a generic drug is bullshit before it hits the market. We can’t have that.
- Switch from brand Topamax to generic once and it’s not too bad, but switch to yet another generic (and another, and another) and it can really mess you up.
- Even something ancient like phenobarbital can’t always be trusted. You should be thankful you don’t live somewhere … Oh, wait, this is the Internet. You just might live in Mauritania, or somewhere else where phenobarbital is a first-line treatment for epilepsy.
- Money is the one argument the generics usually win. Not this time. Here are two studies that looked at the total costs switching people from brand to generic AEDs. While Economic burden associated with the use of generic antiepileptic drugs in the United States could easily be filed under “how to lie with statistics,” Generic antiepileptic drugs and associated medical resource utilization in the United States has hard, actuarial numbers that make a lot more sense. “Such as 20% increased risk of injury” during the period in which they were taking the generics.
- As for psychiatric applications…
- It’s not cheaper for the hospitals to switch your crazy meds. As with AEDs it can cost hospitals more money to deal with symptom relapses.
- Symptom relapse after switch from Celexa to generic citalopram
- I haven’t found anything regarding bupropion HCl vs. bupropion HBr, but paroxetine…
- Paroxetine mesylate: comparable to paroxetine hydrochloride?
- Adverse effects after switching to a different generic form of paroxetine: paroxetine mesylate instead of paroxetine HCl hemihydrate.
- While it’s not just crazy med per se, amlodipine is a calcium channel antagonist, and down the list of off-label treatments for bipolar disorder. This study looked for accounts of differences between amlodipine besylate and amlodipine maleate.
- The difficulty with reports of problems with meds of different salts is how much was due to the active ingredient and how much was due to excipients.
- Here’s a report on seven people inadvertently switched from Clozaril to generic clozapine. They were in a long-term, residential facility and had their schizophrenia symptoms under control. After the switch they “experienced a rapid and profound deterioration.”
- As if you didn’t have enough to deal with when taking lithium, controlled-release products aren’t necessarily all that controlled. If you can’t get brand Eskalith or Lithobid, try to get Roxanne’s generic.
- Lack of BE between brand and generic amoxicillin
- This Danish study found no significant difference in the blood plasma levels of people taking brand Lamictal and those taking generic lamotrigine.
- Comparing Depakote with valproic acid usually pisses me the hell off, but in this blatantly pro-generics study, they admit the two are different drugs. The results: although they ended up taking more valproic acid, and the GI side effects sucked more, there was no difference in how many people stopped taking either med. Although the people taking Depakote were on it a hell of a lot longer than those taking valproic acid.8
- There are probably more, but searching for this sort of thing is like looking up side effects on teh InterGoogles, complaints will always outnumber reports of everything being just fine, because hardly anyone reports “I didn’t have any side effects.” A bit further down I’ve got a bunch of clinical trials where the generics tested as well as the branded versions…
In case you were wondering how all the accidental and “inadvertent” switches happened, this study, 30% of doctors and pharmacists randomly selected from a teaching hospital were unable to identify any of the three meds placed in front of them.
Medicine Is The Best Medicine
Vaccines Cause Immunity
Brain Cooties Aren’t Contagious
Suicide Is Murder
Let’s start with the good news. Of sorts. The FDA admitted that Impax & Teva were wrong, the 300mg size of their Budeprion XL is not bioequivalent to a 300mg tablet of Wellbutrin XL. And only the 300mg tablet. Why? Because Impax didn’t use a 300mg tablet when they did the tests, that’s why. It doesn’t matter that the results were the same. By not using a 300mg tablet in any of the tests, the FDA was able to make Impax do it again, get the same results, and then declare that size to be unclean and not kosher.
Since the FDA has finally admitted that what I’ve been writing for the last 10 years is possible, and they are in the process of testing generics on the market for bioequivalence, there’s no need to flog that dead horse. If you’re interested, here’s a page on some of the history of the Budeprion XL vs. Wellbutrin XL debacle, and all the reasons why the FDA was full of shit and denial on the subject of generic drugs. Still no word on when they’re going to apologize to everyone they said was just imagining the symptoms; or it was just a coincidence and brand Wellbutrin would have failed, so they should try another antidepressant.
So what’s the takeaway from all this?
Significant problems caused by the differences between brand-name drugs and their generic ‘equivalents’ are infrequent but real.
What do I mean by “infrequent?” Based upon all of the examples I’ve used, and all the ones I didn’t include, and all of the anecdotal accounts I’ve come across, problems caused by switching from brand medications to generic drugs or one generic drug to another generic drug comprise, at the very most, 1–2% of the adverse reactions / negative experiences / “side effects”-that-aren’t-really-side-effects everyone has had with crazy meds from the 1990s until now. Maybe. Extrapolating adverse reactions caused by allergies and/or sensitivities to excipients in both branded and generic meds, including those mistaken for side effects of the actual active ingredient, increase that to, at the very most, 5%. That’s my best guess9. I honestly don’t think it’s much more than that.
However 2% is the approximate rate of schizophrenia, and 5% is approximately how many people have affective mood disorders serious enough to require medication. 2–5% is an unacceptable number of people. I’m an outlier in many ways, as are most of the people on Crazy Talk, and we’re well below 1% of the crazy population, which puts us way under 0.2% of the general population. 2–5% is too much.
I have no clue at all what the numbers are like for other dosage-critical and narrow therapeutic margin meds, like those used to treat cancer and immunosuppressants for organ transplants.
As it stands…
- With some people a slight change in a med’s PK can cause a change in side effects and/or relapse of symptoms.
- With other people, a different inactive/inert ingredient/excipient is all that’s needed to cause new side effects.
- The two are not mutually exclusive groups.
- The FDA doesn’t give a rat’s ass about it, otherwise they’d institute real tests and not more of the same bullshit PK testing.
- Which allows Bigger Pharma to keep forcing the generics manufacturers to spend more money on lawyers arguing about FDA-approval for the generic drugs instead spending it on real testing.
- And PK has absolutely nothing to do with allergies & sensitivities to inactive/inert ingredients/excipients. You’re on your own with that.
- Good luck getting the FDA, or Congress, to mandate highlighting any ingredients that cause people those sorts of problems. The most I’ve seen, as far as neurological and psychiatric medications are concerned, is mentioning if there’s lactose in a pill, and that’s buried in the PI sheet.
- So in the end, we’re fucked. The pioneering companies will get to keep FDA exclusivity for their meds longer, keeping the prices up; and we won’t really know which generic versions, if any, are truly equivalent until most of us are paying to take them for a year or more, instead of a couple hundred or so getting paid to take them for 30–90 days.
- Which means we have to always be on guard about which versions we get from our pharmacists. As if our lives weren’t difficult enough. At least we have some tools.
- There’s an entire forum on Crazy Talk dedicated to issues with switching to/between generic meds.
- I have a section on some of the drug pages listing and known differences between brand and generics, and if there are any preferred generics (e.g. Lamictal vs. various generic lamotrigine products).
- While I’ve been writing about the differences between brand and generic meds since 2004, the site that started the uproar about Budeprion XL is The People’s Pharmacy. They have an entire section to report all sorts of medical problems. As far as crazy meds go, that site is almost all antidepressants.
- In any event, there’s not a damned thing we can do about it. Congress won’t act, let alone overreact, unless you’ve got a bunch of weeping mothers telling them, and the two dozen people watching C-SPAN, the stories of the children who died of socially-acceptable conditions like cancer, or something requiring an organ transplant, because of substandard or allergen-packed generic medications.
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2 Want to know the difference between the non-narcotic (i.e. without the hydrocodone component) prescription versions of Aleve and Advil and the regular stuff you can just walk into any store and buy? The dosage is twice as much. That's it. As long as you don't have any other health conditions involved and aren't taking any meds that can interact with them, you can safely take twice as much naltroxen sodium and ibuprofen as listed on the bottle. But if you weren't taking a shitload of meds and/or had an otherwise clean bill of health you probably wouldn't be reading this site in the first place, would you?
3 You just assumed I meant American Medical Association, didn't you?
4 This gets super complicated. The short explanation is: The FDA will let drug companies keep exclusive rights to sell their brand name drugs for months, even years, after the patents expire for many different reasons. The main reason being they have really good lawyers.
5 What the FDA calls its big book about generic meds. It must have been orange at one point. I don't even know if they still print it out on paper.
6 And plenty who did.
7 I usually can't find other useful ones like volume of distribution (VOD).
8 I also wonder if anyone who was severely crazy enough to be hospitalized for a long time then allowed back outside is going to bitch about side effects that much in the first place. Wanting to spench every day sucks, but it sucks a lot less than hearing the people in your bathroom whispering their latest plans about how they're going to kill you.
9 I.e. Numbers I pretty much pulled out of my hemorrhoid-laden and frequently-constipated ass.
Brand Name Vs Generic Medications by Jerod Poore is copyright © 2011 Jerod Poore
|Last modified on Tuesday, 10 June, 2014 at 12:37:17 by JerodPoore||Page Author: Jerod Poore||Date created: 26 February 2011|
All drug names are the trademarks of someone else. Look on the appropriate PI sheets or ask Google who the owners are. The way pharmaceutical companies buy each other and swap products like Monopoly™ real estate, the ownership of any trademarks may have changed without my noticing.
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Almost all of the material on this site is by Jerod Poore and is copyright © 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, and 2014 Jerod Poore. Except, of course, the PI sheets - those are the property of the drug companies who developed the drugs the sheets are about - and any documents that are written by other people which may be posted to this site will remain the property of the original authors. You cannot reproduce this page or any other material on this site outside of the boundaries of fair use copying without the express permission of the copyright holder. That’s usually me, so just ask first. That means if want to print out a few pages to take to your doctor, therapist, counselor, support group, non-understanding family members or something like that - then that’s OK to just do. Go for it! Please. As long as you include this copyright notice and something along the lines of following disclaimer, I’m usually cool with it.
All rights reserved. No warranty is expressed or implied in this information. Consult one or more doctors and/or pharmacists before taking, or changing how you take any neurological and/or psychiatric medication. Your mileage may vary. What happened to us won’t necessarily happen to you. If you still have questions about a medication or condition that were not answered on any of the pages you read, please ask them on Crazy Talk: the Crazymeds Forum.
The information on Crazymeds pertains to and is intended for adults. While some information about children and adolescents is occasionally presented (e.g. US FDA approvals), pediatric-specific data such as dosages, side effects, off-label applications, etc. are rarely included in the articles on drugs or discussed on the forum. If you are looking for information regarding meds for children you’ll have to go somewhere else. Plus we are big pottymouths and talk about S-E-X a lot.
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1 While there are plenty of books to help you with hypochondria, for some reason there’s not much in the way of websites. Then again, staying off of the Internet is a large part of curing/managing the disorder.
2 Remember kids, Microsloth operating systems are like TOS Star Trek movies with in that every other one sucks way, way more. With TOS Star Trek movies you don’t want to bother watching the odd-numbered ones. With Microsloth OS you don’t want to buy and install the even-numbered ones. Anyone who remembers ME and Vista knows what I mean.
3 Have I mentioned how open source operating systems for commercial applications is one of the dumbest ideas in the history of dumb ideas? I don’t even need my big-ass rant any more. Heartbleed has made my case for me. And that’s just the one that got all the media attention. The very nature of an open source operating system makes security as much of an illusion of anonymity. Before you flip out too much: the domain Crazymeds is hosted on uses a version of SSL that is not affected by the Heartbleed bug. That’s one of the many reasons why I pay a lot of money and keep this site on Lunarpages.