General Question

rojo's avatar

Are generic drugs inferior?

Asked by rojo (15989 points ) October 23rd, 2012

A friend who is on depression medication has tried several kinds and has found one that works for her. Her insurance has decided they will only cover a generic version of said drug. She has tried it in the past and swears it did not work for her the way the brand name one does. She has said it is not just the side-effects of the generics but the way it does so much less for the depression. Her doctor concurs with her and between the two they are fighting with the insurance.
So, is she correct? Would not the main ingredient of a generic be the same as the original? If so, why would it not work as well? Is it the buffers? Can a generic use different buffers and still be the same drug? Could it be that the actual drug is enhanced by the buffers and if so, are they still buffers?

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12 Answers

dabbler's avatar

A generic has to have the same active ingredients as the brand name. But you’re right that the differences can be in type and amount of buffers and binders. The release of the drug should not be much different than the original however or you’d have a distinct medication.

Someone who is being treated for depression might be psyching herself out about the generic drug. But maybe not. Those mood-altering drugs are so peculiar anyway and different people react to them differently.

nicole29's avatar

As @dabbler said, they should be bioequivalent, as in – same active ingredients, same exposure time, same absorption, and sam elimination. Most generics work just fine.

Anti-depressants and anti-psychotics are a whole different issue, as there is really no way to mark whether they are working, other than by the patient’s own descriptions, which may change due to a number of things (even unrelated to the drug itself). The fact that her doctor is working with her is in her favor, though. A lot of health plans will allow you to switch back to the brand if you can prove that you’ve jumped through enough hoops with the generics, and all other covered options – and that none of them work. Unfortunately, that can take a lot of time, especially with medications that take many weeks/months to even show symptom improvement.

marinelife's avatar

There are variances in generic. Sometimes they work just as well as the brand name and other times and on other patients, they don’t.

If the doctor specifies the brand name, the insurance usually has to cover it.

JLeslie's avatar

Generics can sometimes vary up to 20% of the actual absorption of the medicine in the pill. So, the dose might actually be too low for her on the generic.

Antidepressants are tricky. There was a very large study recently that showed almost no difference between placebos and antidepressants for mild depression. It does not mean the drug does not work, but it does mean placebos work too. It implies the that the patient having the belief the med works matters for this type of illness. In temrs of side effects, she might be having a reaction to the inactive ingredients.

wundayatta's avatar

We have a psychopharmacologist who occasionally visits our group. I don’t remember exactly what he said, but there are a lot of technical things that can affect the effectiveness of a drug. I think there are binders, for example, than can block the effectiveness of the drug. There are time release pills that work, and the generic isn’t time release and that messes you up badly. There are other things that make a big difference, even though the formula is technically the same, it just doesn’t deliver the med right. In some cases, it can actually be dangerous.

I would find a psychopharmacologist who could investigate the actual formula for the generic, and you could probably prove why it doesn’t work.

linguaphile's avatar

I got the same percentage from my doctor as @JLeslie stated— he told me that brand names must be within 3% of the patented amount of actual medicine in the pill. Generics only have to be within 20%. This information came from my doctor and, in retrospect, I’m surprised he told me this.

I am very sensitive to medicines. When I took metformin, I could tell when the pharmacy changed generic brands—I could feel the difference. Same with my birth control pills—I get a bit more nauseous on the first week with brand name pills than the generic, but get worst cramps on the last week with the generic than with the brand name ones.

They are different and I get really angry when the pharmacists try to convince me otherwise, like I’m too stupid to know my own body.

BhacSsylan's avatar

Here’s a great article on generic drugs and bioequivalence: Generic Drugs: Are They Equivalent

The general upshot is, mostly, no, they are not inferior. There are a few inaccuracies going around, so taken one by one:

“as there is really no way to mark whether they are working, other than by the patient’s own descriptions”

This isn’t true for the testing of generics. This is true in terms of a patient’s response, if they say it isn’t working it probably isn’t working, but not in how generics are found to be viable. They are tested via the amount of active drug circulating at various time points after ingestion (bioavailability) , and thus is not dependent on how the patient feels about it.

“If the doctor specifies the brand name, the insurance usually has to cover it.”

Not really about generics, but this is very much not true (at least not in the US). Insurances have their own lists of drugs they carry, and can exclude brand names. And usually they will just not cover all of a certain kind of drug, and generics are suggested because they are affordable despite not be covered, not because they are covered.

And this: “I don’t remember exactly what he said, but there are a lot of technical things that can affect the effectiveness of a drug. I think there are binders, for example, than can block the effectiveness of the drug. There are time release pills that work, and the generic isn’t time release and that messes you up badly.”

Both of those are not true, because if you block absorption, you block bioavailability, which is how equivalence is tested. So you can’t have a time-release pill and a non-time-release pill be bioequivalent. Unless the time-release aspect is false or ineffective, I guess. However, there can be issues with things like allergies, as binders that do not affect the bioavailability can be different.

However, the 20% figure is correct, and that’s because that’s generally taken as the line of ‘clinically significant’. That is, that’s the point at which you’d normally start to notice differences in groups of patients. However, that doesn’t mean that a single patient may not notice a difference. On the other hand, however, most systematic reviews have failed to find a systemic difference in outcomes between generics and name-brand (links in the article I linked), which supports the clinical insignificance of the differences.

As also has been noted, placebo effect can play a role, and psychiatric disorders are many times highly affected by it, more then other disorders because of how it works. As a result, it’s not hard to believe that your friend could be suffering from just a lower dose, just placebo effect, or a combination of the two.

rojo's avatar

While I do not doubt the 20% absorbtion difference stated, that being the case, it would seem like the pharma’s would cut back on their own dosage. Or would that trigger a new round of tests being required?
I will say that there is a marked, as in a much, much reduced suicidal tendency, difference between the drugs I have seen her on over the past two years and the one she has been on lately; the one they don’t want to cover.

Thanks to all for all the information given!

BhacSsylan's avatar

No, if the pharma company lowers their own dosage, they must sell it as a different product (eg Prisolec 10 mg and Prilosec 20 mg are different drugs), and the generics must be matched to a given dosage (so Omeprazole 10 mg and 20 mg).

Also note that most pharma companies, when their drug hits generic, will start selling some of their own drug as generic (why give up profit purely to other companies if you can grab some for yourself?), and so there’s usually at least one generic version that’s the same as the name-brand, just relabelled. But which one that is usually hard to tell.

Rarebear's avatar

Speaking as a physician, generic drugs are not inferior. I take several medications myself (high blood pressure, cholesterol, allergy, etc.) and they are all generic. That said, I have patients who are absolutely convinced that generics don’t work as well for this or that. It mostly probably is confirmation bias, but I’ll usually write them with the “do not substitute” moniker if they insist. Health plans won’t always pay for them, although I will ask.

JLeslie's avatar

One thing I have noticed with some generics is their shelf life seems to be shorter. Well, maybe the drug has not lost any efficacy, but certain generics I take, the pills start to break apart and change color very fast, while the brand is fine for years. Although, some generics I have not found this to be true at all, and even after 6 months the pills are fine. I have never seen a brand pill come apart like that though.

I take generics, including I have taken generic thyroid medication, which is very sensitive to dosage requirements, and I have never had a generic not work as well as a brand although with my thyroid med, when I have switched from one generic to another I had to go slightly up in dose, but then while continuing on that generic the dosage needs stayed exactly the same, so I am confident each generic is consistent from pill to pill from that particular manufacturer.

I do sometimes ask for brand if the generic is hard for me to swallow, as generic pills tend to be bigger, not coated, and less likely to be capsules. Sometimes I can just get a lower dose pill and take two, and stick with taking the generic. It costs more to take two pills, but still is often cheaper than getting one pill of brand.

GracieT's avatar

As has been said before, weaning your body is the best way to come off. Generic drugs are often just cheaper ways to make the same medicine I’ve been told, but I’ve also been told that some medications, like anticonvulsants are not safe to take as generic because while the actual medicine is the same the fillers are not regulated and could make the difference in efficacy.

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