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  #1  
Old 07-24-2002, 10:53 AM
thimblegirl thimblegirl is offline
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Are generic drugs as effective as name brands?

I don't care what the FDA says. From personal experience it seems generics don't work as well. What has your experience been?
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  #2  
Old 07-24-2002, 10:58 AM
cher3 cher3 is offline
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I take generic prescriptions and store brand drugs whenever I can. I've never had a problem. Drug prices are outrageous and I like to circumvent them whenever possible.
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  #3  
Old 07-24-2002, 11:02 AM
UDS UDS is offline
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There may be a placebo effect associated with using the branded product.

Do the producers of branded products claim that their products are more effective than the generic equivalent? If there was any evidence of this I'd expect them to be trumpeting it from the rooftops.

My experience is that generics are just as effective.
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  #4  
Old 07-24-2002, 11:26 AM
Corrvin Corrvin is offline
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IANAPharmacist, but I did have a long talk with one one night while helping him with his computer, and here's how he explained it to me.

Take a name brand tablet, say of ibuprofen, and a generic one. The name brand one may be coated (as Nuprin is) with a specific coating which is their trademark, so the generic won't. Ignoring that, they'll be labeled as containing the same amount of medicine, but the name brand is more tightly controlled as to how it'll enter your body.

Imagine a pill-stamping machine that's turning 200 mg of ibuprofen into a pill form. Obviously there's a continuum between loose powder and the most tightly compacted pill you can imagine; in the loose powder form, it tastes like crap and gets stuck in your teeth instead of going down your throat, and in the compacted form it goes right out the other end, having never dissolved in your intestinal tract and leaving you with the same headache. The ideal state is to compact it so that it dissolves in the appropriate place in your digestive tract, and not before or after that.

The name-brand is very specific about the amount of pressure used to make their tablet, while the generic is usually not so specific. In fact, they may be made in the same factory, and the generic is the not-quite-up-to-written-standards reject. If you take the generic pill, you may in fact get your 200 mg of ibuprofen in the right place at the right time, or you might get only 190 mg, the first 5% having dissolved in your esophagus, and so on. But the name brand and generic tablets contain exactly the same amount of drug, and that's what the FDA cares about.

I don't mean to say that taking generics is bad. I take generic ibuprofen myself, and other generic drugs when I'm sick. I have other things to worry about than losing 5% of my drug's effectiveness, even on something so annoying as a headache.

Corr
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  #5  
Old 07-24-2002, 11:48 AM
Achernar Achernar is offline
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I don't take drugs often, but when I do, I try to take the name brand. Not because it's better, but because they're the ones who paid for the research, and I think that they should get the profits. Am I right about this?
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  #6  
Old 07-24-2002, 12:07 PM
erislover erislover is offline
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Generic pills will have the same medicine. The reason they're generic, as far as I know, is because the original patent has expired and the chemical is now in the public domain. Generic pills have to meet the same standards as the name brand pills.

As far as coating goes, that's an issue I hadn't quite thought of. What is important is that the right dosage of medicine enters your blood stream. To do this, the pill has to dissolve at the right time. If it doesn't, the medicine might not be available, it might decompose in the stomach, or something else that I'm just not going to get into a detailed discussion of.

I can't imagine why a generic drug wouldn't be biochemically available in the same way that a name brand would or the drug (probably) wouldn't really work at all. I've never read a drug patent, though, so I don't know if all the information is there for the taking (where in the intestine it is best absorbed, etc). That information has to have been obtained, however, or the drug would have never come to market.

Interesting.
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  #7  
Old 07-24-2002, 12:10 PM
UDS UDS is offline
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Well, they'll have had an exclusive patent for a period, and that's the time during which they get the payoff for the research. If the generic is available, the exclusive patent has expired. Do you still feel obliged to pay them for developing the drug?

Besides, not all branded drugs are actually produced by the people who developed them. For example, several different branded versions of paracetemol are available, as well as generic paracetemol. Only one (at most) of the branded versions comes from the company that developed the drug. The rest have simply established a branded version which they advertise heavily, and they hope that the advertising will help them to pick up more sales, despite the higher price. If you buy those, it's the advertising you're paying for, not the development of the drug.
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  #8  
Old 07-24-2002, 12:16 PM
Achernar Achernar is offline
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Quote:
Originally posted by UDS
not all branded drugs are actually produced by the people who developed them.... The rest have simply established a branded version which they advertise heavily
That's what I was asking, thank you. Does anyone know a good resource for determining who first developed a certain drug?
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  #9  
Old 07-24-2002, 12:20 PM
erislover erislover is offline
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Ok, I've just gone and talked this over with our chemists. Here's the deal, but it's kinda tricky.

First, yes, all the information is explained. When I say "all", I mean, what the drug structure is, the general method to produce it (not detailed instructions which could be proprietary), the levels that are achieved in the blood to achieve what effects (dosage profile, basically), when it is available for the blood, etc, etc, etc. Patent expires, public domain, anyone can do exactly the same thing (and they do). Figure a good 300 pages of information.

The matter is tricky now, though. Apparently a certain company has either taken advantage of a loophole, or a new law has been enacted WRT patents, which allows them to patent the actual method of delivery, including the specific levels of medicine in the blood. The company has filed this patent much later in the game (since no one could make the drug anyway), and by the time the drug patent expires the method of delivery and execution is under patent, theoretically doubling patent life.

I won't mention the company that has tried this, but their AIDS drug patent is about to expire and they have gone this route. AFAIK they are the first to attempt this, and so far no challenge has been raised. [aside]This is total BS, it effectively doubles the patent life, and I hope to hell that our legal system doesn't let this continue.[/aside]

This means that any generics that are made must achieve differnent quantities in the blood, different dosages, time delivery, etc. Again, tihs is new (as far as our chemists here explain it to me). Up to this time, generics and name brand are not significantly different in their effects. However, given this new route of patents, the affects will be required to be different to avoid patent protection, so generics will be necessarily different.

Strange world, and again, IMNSHO this second-round patent is total garbage.
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  #10  
Old 07-24-2002, 02:14 PM
Exapno Mapcase Exapno Mapcase is online now
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One more thing to consider. Pills are more than drugs. The amount of the active ingredient of many drugs is often too tiny to grab hold of. Every pill I am familiar with has one or much more often an assortment of inactive ingredients. These have several purposes. Not only do they bulk out the drug, but they may help the pill dissolve, make it less bitter tasting, prevent it from caking, create a time release effect, or any number of other things.

If you look at a series of pills even from the same manufacturer you will notice differences in the inactive ingredients. For some pills, even as slight a variation as the 25 mg dose v. the 50 mg dose may have radically different ingredients.

If these variations make a difference, imagine how great the differences might be from one totally different manufacturer to another all trying to make a pill from a tiny quantity of active compound.

Now add to this all the other variables -- manufacturing processes, experience in working with these particular compounds, level of staff expertise, quality assurance variations, etc. -- and it's a wonder that most generics do indeed work just as well as the original patented medication.
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  #11  
Old 07-25-2002, 12:39 AM
Telemark Telemark is online now
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Generics are subjected to tests where they check the level of the drug delivered to the bloodstream vs the original drug.

Drugs may vary from lot to lot, let alone from generic to pioneer. But the level of quality of all drugs are so high as to not really worry about the difference.
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  #12  
Old 07-25-2002, 02:09 AM
kspharm kspharm is offline
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I am a pharmacist, and as such, I can tell you that 1) With absolutely no intererest in you switching from brand name drugs to generics, it will save you money, it is the exact same freakin' drug (regulated by the FDA in the USA), 2) It is absorbed exactly the same way, and 3) the generic drug will do the same thing that the brand name drug is supposed to. I am a pharmacist (as I said), but honestly, I could care less if you went for a brand name drug or its generic counterpart. If you had half a brain and researched it, you would realize that generics are equivalent in every way, shape, and form, to brand name drugs. The only reason people are still using brand name drugs which have generics are that they feel that the "brand name" is superior (placebo effect) or that their doctor tells them to take it (drug rep. influence). Recently, I had a case of bronchitis which required a trip to the Neighborhood Doctor (a walk-in clinic). The doc prescribed an antibiotic, a decongestant, and an expectorant/antihistamine. She openly told me that she preferred the decongestant and expectorant because the drug rep that had visited her was a friend and she was getting samples of the drug. She wrote "brand name medically necessary" and gave me 6 refills on both of those drugs (mind you, this is after informing her that I was a pharmacist). I thought that this was both highly unecessary for her to give me 6 refills, and, unwarranted, to write "medically necessary". Re: generic drug formulations for drugs that have a narrow therapeutic index, please e-mail me: there are studies that show that even for those drugs, there is absolutely no reason to mandate for brand names.
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  #13  
Old 07-25-2002, 02:38 AM
don't ask don't ask is offline
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Some years ago I worked for a short time for a family that owned a small pharmaceutical company. The husband told me that many common brand name drugs cost more to package than the drug costs to make. He was very scathing about buying blister packed drugs that you could buy loose in a bottle.
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  #14  
Old 07-25-2002, 02:40 AM
kspharm kspharm is offline
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Quote:
Originally posted by Achernar
I don't take drugs often, but when I do, I try to take the name brand. Not because it's better, but because they're the ones who paid for the research, and I think that they should get the profits. Am I right about this?
Yes, the company that researched and developed the drug is the one who paid for the research, but they re-coup their money. That is what patents are for. After a certain period of time, the company who discovered the drug has made all of their money back, made millions (even billions) of dollars in profit, and controls most of the market for that particular drug. But, whence their patents run out, other (generic) manufacturers may step in and make the EXACT same drug and sell it to the public for a fraction of the price. IANAP(patent)L, but it seems fair to me that after a certain period of time, any product that has been out on the market for years should be made available to produce for any company. Take xerographic machines, cameras, etc. The problem is that these days, the original developers of the drug are trying to extend the patent life of their medication by, at the last minute, applying to the FDA for new indications or formulations which are trivial but nonetheless breathe new life into a drug which is about to go off-patent. Take for example, Glucophage. This is a diabetes medication which has been around for years - but only in the last couple of years, when the brand name formulation was about to go off-patent, that the manufacturer decided to introduce a reformulated version - Glucophage XR (extended release), and then spent millions to get patients and providers to understand the benefits of using an extended release version of a pretty old drug. This is not new. Many companies are doing the same thing - Eli Lilly has pumped up Sarafem as a new drug for treating pre-menstrual dysphoric disorder, even though it is the exact same thing as generic Prozac. Astra-Zeneca is touting Nexium as a breakthrough drug, even though it is the same thing (in your body) as Prilosec is, considering that Prilosec is going to become an over the counter (and generic) drug in the next few months. Ehh, I guess that if you don't research what you are paying for, then you are at fault - but I always like to think that people are not that gullible. KSPHARM, RPh.
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  #15  
Old 07-25-2002, 07:15 AM
miatachris miatachris is offline
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This is my personal list of drugs that I do not recommend generics on -

Lanoxin (narrow therapeutic index, brand usually comparable in price to generic)
Oral Contraceptives (risk-reward doesn't work for me here)


Don't switch back and forth between brand and generic on -

Dilantin / Phenytoin
Coumadin / Warfarin
Tegretol / Carbamazepine
Thyroid meds

Pick one and stay on it. Bouncing back and forth makes it real hard to get your levels straight.

Those exceptions taken care of, I like generics. They're good drugs, they're cheaper to stock and cheaper on the patient.


KSpharm has done a good job explaining the patent extension problem. I'll go ahead and name some more names, though.

Clarinex is the biggest crock. Clarinex is NOT a new drug in any way, shape, or form. Clarinex is what is known as the "active metabolite" of Claritin. The simple way to explain it is --- when you take Claritin, the first thing your body does to it is to change it to Clarinex. Sooo - you've been on Clarinex the whole time as a Claritin patient anyway! Schering is looking forward to billions on this one. For God's sake - take the generic Claritin when it comes out, not the Clarinex.

Are you taking Zocor? Ask your doctor to consider Lovastatin (Generic Mevacor). The drug structures are so so close as to be almost identical. Except that Zocor is still brand.


I used to use an analogy when discussing brand/generic like this-- "You wouldn't pay more for someone to use "brand-name" electricity, would you?" Lately, though, the local utility has been selling "green" power for a few cents more/kWh. They are doing real well with it, too.

miatachris, R.Ph.
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  #16  
Old 07-25-2002, 07:26 AM
KidCharlemagne KidCharlemagne is offline
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KSPharm,
Your name makes me think your a pro but I have to disagree with you on at least an amateur clinical level, at least on some drugs. I would have sworn on my future grave that there would be no difference in generic vs. brand. I have always, however, noticed a big difference in ibuprofen and ritalin sr. My suspicion regarding ritalin has been confirmed by many doctor's clinical observations regarding the generic (sorry no site but ive read it in at least a couple of places.) Sure there is always observer bias but I'm someone who was always believed they would be the same.
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  #17  
Old 07-25-2002, 08:46 AM
Achernar Achernar is offline
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Quote:
Originally posted by kspharm
IANAP(patent)L, but it seems fair to me that after a certain period of time, any product that has been out on the market for years should be made available to produce for any company
Okay, that seems reasonable. Thank you for the explanation. I didn't mean to say, though, that I found the patent laws unfair. Nor was I trying to convince anyone of a course of action; I was just trying to say why I do what I do. It seemed relevant, anyway.
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  #18  
Old 07-25-2002, 09:23 AM
erislover erislover is offline
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Well, Achernar, that's the whole idea behind brands in the first place... to get you to stick with the higher cost. The Brand should represent higher quality. Given the huge amount of restrictions on drug manufacture (as opposed to, say, vacuum cleaners), it is doubtful that you are supporting much of anything after a patent has expired other than the pharma's desire ot make money.

kspharm, you might want to mention other drugs which have been reformulated and targeted for different things. For instance, a drug used to treat depression, off patent. But if you sought the same therapy for quitting smoking (I think this is the one, or was it the menopause therapy?) the doctor would not be able to prescribe you the generic because of a reformulated patent.

[aside part II]Pure, unadulterated rubbish.[/aside II]
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  #19  
Old 07-25-2002, 11:41 AM
toadspittle toadspittle is offline
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Quote:
Originally posted by miatachris

Don't switch back and forth between brand and generic on -

Dilantin / Phenytoin
Coumadin / Warfarin
Tegretol / Carbamazepine
Thyroid meds

Pick one and stay on it. Bouncing back and forth makes it real hard to get your levels straight.

I agree here. My mother is on Thyroid meds, my dad on a number of different meds for Parkinson's, and nailing down the proper dosages/delivery methods/times of day/etc. for each of their drugs has been a 20-year learning experience, which they finally have pretty well tuned now. They recently had to switch to generics for insurance reasons, and it royally screwed them both up. For some precision drugs (esp. where neurotransmitters are involved), it really DOES matter what you take. For things like painkillers or decongestants, which is much less exact, it prob. doesn't matter.

Quote:

I used to use an analogy when discussing brand/generic like this-- "You wouldn't pay more for someone to use "brand-name" electricity, would you?" Lately, though, the local utility has been selling "green" power for a few cents more/kWh. They are doing real well with it, too.

miatachris, R.Ph.
Hmm. Not a very good anlogy, IMO--arguing conscience (energy) vs. confidence (drugs).
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  #20  
Old 07-25-2002, 02:23 PM
erislover erislover is offline
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But the reason we have the FDA standards is to take confidence out of the running. If you meet the requirements for drug delivery, you can't do it "better".
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  #21  
Old 07-25-2002, 02:39 PM
ftg ftg is offline
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I take a prescrip. med. and noted a small difference between generic and name brand: The generic gives me heartburn. The old insurance co. was okay with the name brand (it's an old drug so it wasn't that much more expensive) but the new co. only fully covers the generic. So, extra water and a little bit of food every night.

So I agree with erislover on this.
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  #22  
Old 07-25-2002, 03:42 PM
miatachris miatachris is offline
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Quote:
Originally posted by toadspittle
Hmm. Not a very good anlogy, IMO--arguing conscience (energy) vs. confidence (drugs).
I did say used to. Not a good analogy any longer might have hit it better, though. I'll try to be clearer.
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  #23  
Old 07-25-2002, 06:41 PM
kspharm kspharm is offline
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Quote:
Originally posted by miatachris
This is my personal list of drugs that I do not recommend generics on -

Lanoxin (narrow therapeutic index, brand usually comparable in price to generic)
Oral Contraceptives (risk-reward doesn't work for me here)


Don't switch back and forth between brand and generic on -

Dilantin / Phenytoin
Coumadin / Warfarin
Tegretol / Carbamazepine
Thyroid meds

Pick one and stay on it. Bouncing back and forth makes it real hard to get your levels straight.

Miatachris,
As you know, all of these drugs are on the so-called "negative formulary" of one state or another because there has been a strong misconception for quite a while that bioequivalence is not the same between brand and generics for these drugs. If you read the article "Narrow therapeutic index generics: Sound alternatives to brand drugs" in the June 2002 supplement to Drug Topics, they summarize pretty much all the bioequivalence trials for all the drugs you named (except the oral contraceptives). Their conclusion is that you can substitute for the brand name drug with no consequence. For some drugs, the generics actually gave better results, e.g. the generic warfarin product by Barr had less intrasubject INR variability than Coumadin (which basically means that the generic anti-platelet drug produced more consistent results than the brand). But I do agree with you that once a patient is on a specific brand or generic for a narrow therapeutic index drug, it is probably a better idea to leave them on whatever it is they're taking. As far as the oral contraceptives go, the generics do not offer much price competition and some insurance companies will only pay for the brand anyway.

Quote:
Originally posted by KidCharlemagne
I would have sworn on my future grave that there would be no difference in generic vs. brand. I have always, however, noticed a big difference in ibuprofen and ritalin sr. My suspicion regarding ritalin has been confirmed by many doctor's clinical observations regarding the generic (sorry no site but ive read it in at least a couple of places.) Sure there is always observer bias but I'm someone who was always believed they would be the same.
As far as bioequivalence between brand and generic goes (bioequivalence meaning comparing the peak plasma concentrations and extent of drug absorption, Cmax and AUC), the FDA has given Ritalin and its generic counterparts a rating of AB, which means it considers them to be bioequivalent. Ritalin SR is a different, extended release version of Ritalin. So depending on which formulation was used, sure, the Ritalin SR will work longer than the generic for the older Ritalin. As far as ibuprofen goes, are you talking about OTC Motrin and Advil vs. the store brands? I would say that 99% of the ibuprofen dispensed as a prescription is generic, not brand name.

Quote:
Originally quoted by erislover
For instance, a drug used to treat depression, off patent. But if you sought the same therapy for quitting smoking (I think this is the one, or was it the menopause therapy?) the doctor would not be able to prescribe you the generic because of a reformulated patent
You are thinking of Wellbutrin, which went off-patent a while back, but the manufacturer still holds the patent for Wellbutrin SR which has no generic yet. The manufacturer then gained an indication for smoking cessation for the SR drug, and remarketed it as Zyban. The doctor could and should, in my opinion prescribe the generic for smoking cessation. He could also prescribe Wellbutrin SR, as it is the exact same thing as Zyban. Whether the insurance company will agree to pay for it is a different story. The indications that a drug has is by no means supposed to limit a physician from prescribing that drug for any other reason that he/she believes is warranted. Drug manufacturers like to squeeze every last drop of profit from their products, and who can blame them. But I find it a bit disturbing that they hold off on introducing a newer, better version of their drug at the very last minute. Take for example, Paxil, which is an antidepressant similar to Prozac. It will be going off patent soon. So its manufacturer reformulates it as Paxil CR (controlled release) and is now trying to switch as many patients to the newer form. You don't think that they knew how to make a controlled release form of the drug 5 years ago? Same is true for Prozac Weekly, Ultram (which quickly added acetaminophen and became Ultracet right before its patent expired), Valtrex (it came out right before the patent for Zovirax, which is a precursor of Valtrex, was about to expire), and many, many others.
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  #24  
Old 07-25-2002, 07:52 PM
Markxxx Markxxx is offline
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You should always have your doctor write out your prescription for NAME brands and check MAY SUBSTITUTE

Why? Because in ILLINOIS for example the law states any GENERIC drug substituted for a name drug must be identical to the name brand.

But if the generic is prescribed it doesn't have to be.

I for one am all for generics. I have never found one (even over the counter) to be less effective.
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  #25  
Old 07-25-2002, 10:34 PM
Neurodoc Neurodoc is offline
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Quote:
Originally posted by miatachris
This is my personal list of drugs that I do not recommend generics on -

Lanoxin (narrow therapeutic index, brand usually comparable in price to generic)
Oral Contraceptives (risk-reward doesn't work for me here)


Don't switch back and forth between brand and generic on -

Dilantin / Phenytoin
Coumadin / Warfarin
Tegretol / Carbamazepine
Thyroid meds

miatachris, R.Ph.
I agree as to tthe Dilantin. As a neurologist with a large number of epileptic patients, I think I can say something about the antiepileptic drugs. I have had quite a few epileptics who lost good control switching from Dilantin to generic phenytoin. I thus believe that the brand name drug, Dilantin, is superior, for whatever reasons you can imagine, to the generic phenytoin. Period. End of story. Sorry if anyone diagrees with that, but they are the facts in my humble experience.
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  #26  
Old 07-26-2002, 01:02 AM
kspharm kspharm is offline
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And that is perfectly fine with me. If those are the results you have perceived, than you as an MD are more than justified in specifying a brand name drug over a generic - I only have a problem with those docs who write "brand name medically necessary" for something without researching, or at least inquiring, into it.
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  #27  
Old 07-26-2002, 02:29 AM
susan susan is offline
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I'm a psychologist, and at times my clients have reported getting different effects from name-brand and generic antidepressants. It's after midnight here so I can't put my hands on it, but I know I've read a report comparing an SSRI and its generic. Whether that was a double-blind study I couldn't tell you.

Some posts have mentioned the "placebo effect." It may be worth mentioning that a pill is not just a pill--there's a lot of cultural meaning wrapped up with it. There have been studies showing that the color of a pill can change reports of its efficacy in some cultural groups. Lest anyone scoff at this, I note that "Z," "Q," "V," and "X," the more "scientific"-sounding letters, appear quite regularly in US medication brand names. I assume, but don't know, that market research has shown that we have a preference for these letters, which (I also assume) means that we will put more faith in them. Which would you rather take, a nice Zovirax, Vioxx, or Prozac; or a Glub Flahmmug, or Wumple?
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  #28  
Old 07-26-2002, 09:39 PM
mnemosyne mnemosyne is offline
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Not that I'm an expert, but regarding tests that name/generic brands undergo, they DO have standards, pretty vigourous, for ANYTHING that might eventually be used as medicine.

The Unites States Pharmacopoeia, the European Pharm. and Japan Pharm. are the three main standards I reference at work (physical testing in an outsourcing pharmaceutical company), USP being the most common. Pretty much each and every drug, excipent, or even capsule size/coating colour, etc meets specific standards, and these standards must be maintained not only when the product is made, but also throughout all stages of feasibility, registration and clinical trials. Just recently I ran a stability test on a product requiring it to have the same thickness as 24 months prior. Water content, disintegration, potency, etc are also VERY common tests. Also, as an example regarding the above mentionned compactness: USP has a limit of 1% friability (weight loss) on 6.5g of tablet, run in an abrasion wheel at 25rpm (basically spun at that rate for 4 minutes, and weight difference % calculated). If a drug of a certain type is to meet USP standards, and therefore be acceptable to the FDA, it must pass this test, regardless of brand name/generic. There are also tests on dissolution, and specified limits for delivery type (capsule, tablet, coated, non-coated, etc) in a certain medium (water, or simulated gastric juice) at body temperature. This means that drugs must be delivered at a certain percentage, over a certain amount of time, given a specific delivery type.

These are HIGHLY regulated tests, in a HIGHLY regulated environment. We just recently had the FDA auditing us to determine if all proper procedures were followed so that they can allow a drug to make it to market. They even examined YEARS worth of balance calibration data, to make sure balances had been calibrated every day they were used. One mistake, one day missed, and the entire drug project would have been in big trouble, not to mention the company I work for!

So, no, they don't have less vigourous standards just because they are generic.

(FYI - I'm just a summer student at this company, but I am quite certain about everything I've said, or near enough to still make the above statement ).
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