Yes. Food Club Bean Dip is better than Zapps, Frito Lay, or any other bean dip I’ve tasted.
FWIW, I did several PubMed and google searches and didn’t find any examples of a generic drug that performed better than its brand name counterpart. The MDs around here may know of examples that I wasn’t able to find in my search.
It’s not likely that there’s much clinical data out there to support a generic drug being better than the brand name version, but that doesn’t mean anything nefarious is going on. In the US, the FDA will not approve a generic drug for marketing in the US unless it satisfies several conditions, including the following (per the FDA website):
(bolding added) FDA does not require generic manufacturers to conduct or publish studies comparing the effectiveness of the generic versus the brand name drug, or generic versus a placebo. The generic version of a drug is cheaper, in part, because the generic manufacturer is not required to conduct clinical efficacy trials, which are very expensive. (Also, the generic manufacturer does not have to invest money in research and development to identify the active drug compound, because the R&D work is financed by the brand name drug manufacturer in most cases.) For this reason, there are a relatively limited number of clinical studies comparing the efficacy of brand name versus generic drugs.
In addition, because of FDA’s bioequivalence requirement, the differences in effectiveness of a brand drug and its generic counterpart, if any, should be small. The smaller the difference in efficacy between the brand and the generic, the larger the clinical trial must be to show a statistically significant difference between the two treated populations. (That is, achieving statistical significance to prove a 5% a difference in efficacy would require testing of more subjects (patients) than to prove a 50% difference in efficacy.) Testing more subjects means a more expensive clinical trial. So, the bottom line is that it would be expensive to conduct a clinical trial with enough statistical power to actually measure a statistically significant difference in efficacy between a brand name and a generic.
Here are two articles from WebMD that explain why there could be a difference in the effectiveness of a brand name drug and its generic counterpart. There could also be a difference between the generic version of drug X produced by generic manufacturer A, and the generic version of drug X produced by generic manufacturer B.
(As mentioned, there isn’t much clinical trial data comparing the effectiveness of generic drugs and branded drugs. Doctors may base their opinions of brand versus generic efficacy on anecdotal reports from patients. Also, brand name drug companies spend more money on advertising than generic companies, which may have some effect on doctors’ prescribing preferences.)
Article on epilepsy drugs (see p. 3 for quote)
I just realized that I don’t see a link to this recent column. You’re slipping up, people! It doesn’t answer your question really, but it is germane.
From this, I think I have learned that drug manufacturers, in all the testing they do, determine the best inert ingredients they can find for the delivery of X medication into the patient’s blood stream. Also, generic manufacturers, not having done any extensive testing, use their own best guesses as to what inert ingredients to use. And some studies have indicated that some generics are the same or are inferior to some brand name medicines. And some doctors consider that to be the case, as well.
However, I think that says that it’s likely that there is a conventional wisdom out there, in the public and among doctors, that generics can only be as good as the brand name, but cannot be better. And it seems that it’s certainly possible that the generic manufacturers could come up with an inert ingredient that happens to make the drug work better than the brand name. Clearly, if someone were to find something that could speed the dissolution of the active ingredient - something that the bigger brand name companies had not tested - the generic formulation could actually deliver more of the drug faster than the brand name.
I think that doctors’ prejudices in this regard would make it unlikely that they would recommend generics on the basis of their experiences, subtly rejecting reports of their patients, and skewing their interpretations of their own observations adequately to sway their drug preferences toward the brand name. I would still be interested to know if any doctors choose generics over brand names based on effectiveness. (I do understand that generics are not reliable over time due to different manufacturers).
I have taken a neurological med for about a half century. The generic falls apart in the bottle, is harder to swallow and looks like some other white pills so one must read the label carefully. The brand name had none of these problems but the insurance company won’t allow it. Both seem to have indistinguishable therapeutic effect.
Sorry for butchering your post a little, but I just want to address a few specific statements to the best of my knowledge!
True. They discover drug X, feel it might help cure Y, and come up with recipes to make a dosage form which will deliver that drug to the patient. The chemical properties of X and the timeframe that you want the drug delivered in will help determine the best form: things that degrade easily in acids will be coated to pass through the stomach and release X in the intestine, unless you want rapid action, in which case you consider injections, etc. Fast acting versus extended release dosage forms will have different ingredients in them in order to achieve that purpose.
The available inert ingredients are a finite, but extensive list; the FDA and equivalents have approved certain things for use in drugs, and anything new would have to undergo extensive testing to show that it has no biological effect on it’s own, nevermind the testing to show that it doesn’t affect X. So in a way, both the generic and brand manufacturer for X could have used the exact same things, since they are working from the same “shopping list” so to speak.
This is simplifying things quite a bit. While there’s always guesswork in medicine, the fact is certain inert ingredients are known to work for certain delivery types, so the chemists at company A are likely to choose the same things as those at company B if they are intending to make a certain type of tablet. Like choosing butter instead of margarine, but in most recipes, the difference really doesn’t matter at all, if that makes sense?
As for testing: a generic company will begin to create their formulation for X years before the patent expires, in order to have it ready to sell. They, too, will come up with 2-3 versions and test them against each other and against X directly to compare results. They also do clinical testing - here’s a randomly googled clinical trial currently being run for Apotex, a generics manufacturer. And naturally the generic company does the usual quality control and stability testing on their products.
This is true, I suppose.
The testing I’ve done usually had criteria such as “100% +/- 2% dissolution release in under 20 minutes”, and usually these types of drugs reached that point well before that, in the 5 or 10 minute range. So we never really compared if the generic was at 5 minutes while the brand name was at 7…we just ensured it was less than 20.
Tablets should not be falling apart in the bottle - it should have passed the criteria in USP <1216> Tablet Friability. If this is a regular thing, report it to your pharmacist, who should take the lot number of the drug and contact the manufacturer. I suppose you could contact the manufacturer as well about this.
It’s unfortunate that the tablets happen to resemble other ones you have, but it’s a good idea to always read the labels anyways, just to be sure!
Isn’t there also an issue with some drugs that repute to treat the same condition yet do not have the same active ingredient of the brand name drug? Doesn’t that have something to do with patents? Lipitor comes to mind, as does Nexium.
I recall when I was diagnosed with reflux that Nexium was prescription only…then Prilosec OTC came out (expensive), and now Kroger sells generic Omezaprole that is much cheaper and is basically the same thing as Prilosec.
Damn, what a wonder drug the Prilosecs of the world are! Move over, orange juice, hot peppers and tomatoes, I’m ready to eat!
Changing the medication from one drug to another is called Therapeutic Substitution, and is a totally different thing then changing between a branded drug and its generic. Therapeutic substitution is illegal without the doctor’s permission (at least in Georgia, but I believe in most states). While generic substitution is allowed and encouraged.
Nexium is still prescription only, and just for the record Nexium (Esomezaprole) is actually pretty much the same as Prilosec (Omezaprole). The only difference is that Omezaprole is a racemetric mixture, while Esomezaprole is just the active S-enantimer. However, they are considered two different drugs, so we can’t just substitute them without your doctor’s permission, doesn’t mean we can’t recommend it to you when you complain about the Nexium price.
My apologies for cutting up your post (it’s something I generally don’t like when other people do it), but I couldn’t think of a better way to set up my response.
For brand name companies in the US, there’s a lot more to testing than determining the best inert ingredients. Some examples include synthesizing test compounds and screening in vitro to identify X as a candidate drug, testing toxicity and metabolism of X, determining the proper dosage for X, proving that X is more effective than placebo, determining the side effect profile for X at the effective dosage(s), testing for drug-drug interactions, eliminating potential active drug candidates that do not have a favorable benefit to risk profile, etc.
In the US, generic drugs are tested for bioequivalence and other factors (see post 22 above), but generic drugs are generally not subjected to as extensive testing as brand name drugs. In the US, the generic manufacturer can use information provided by the brand name manufacturer in deciding what inert ingredients to use - the brand drug publishes a list of the inactive ingredients used (but not their relative amounts) as part of the prescribing information for doctors. In some cases all or part of the brand drug recipe is protected by a patent, though, in which case the generic manufacturer would have to come up with its own recipe.
It seems possible that under some hypothetical scenario, a generic drug could be more effective than (or have fewer side effects than) its counterpart brand drug. In fact, there are financial incentives for the generic manufacturer, or for a government in the case of government-funded health care, to identify generic drugs that are statistically or anecdotally more effective than their brand name counterparts, and inform doctors that the generic is superior. (In the specific example you propose, though, speeding up the dissolution rate is not necessarily going to increase effectiveness for all drugs. Different drugs have a different optimal dissolution profiles; in some cases, slower is better.)
Some doctors may be biased against generic drugs; however, the bias might not be quite as bad as you suggest. One problem is that the normal sequence of events is that the doctor treats a patient with the brand name drug while the drug is “on patent.” Once the patent expires, generic drugs can be produced, and the doctor switches the patient over to the generic version of the same drug. After the switch, the patient will be much more likely to report negative information to the doctor (my depression is worse after switching; I had a seizure after switching). Patients typically don’t see the doctor when they are well, so any positive effect of the generic would probably only be mentioned if the patient happened to be seeing the doctor for some other reason. Also, the patient might not remember to mention a positive change to the doctor unless it’s a dramatic change, e.g., a side effect went away after switching. So it may not be the case that the doctor is ignoring anecdotal reports that the generic is better; the doctor may not be getting such reports even if the generic is better.
Of course my personal experience Is Not Data, but I found the generic methylphenidate worked better for me than the name brand Ritalin. I got the name brand only that one time because the pharmacy was short on the generic, and being final exam season I really, really needed my head to be clear and focused. The generic served that purpose wonderfully, while the name brand made me all tensed up and gave me a headache.
Did you tell your doctor that the generic was better? Do you know whether other people have reported the same (that generic methylphenidate is better)? I am genuinely curious. I don’t doubt that what you are saying is true.
ETA: Maybe this was a whoosh (I misread the first time)… Maybe you were tensed up and had a headache because of the finals, not the drug?
I’ve heard it reported on a benzodiazepine forum I frequent that people who are withdrawing often experience more significant withdrawal when switching to generics. The offered explanation was two-fold: people withdrawing benzos are more anxious by nature and more likely to notice minute changes in side effects from different fillers, and benzos are extremely potent, so even a small change in bioavailability can be significant.
Anyways, to these people, whichever version they were originally using (whether generic or brand name) is considered the best.
Another possible difference, besides inactives in the formulation, is the impurities in the API (the active pharmaceutical ingredient, i.e., the drug) itself. A generics manufacturer does not have to and often will not use the same route as the brand-name manufacturer, especially if the synthetic route is covered in whole or part by patent. That’s part of the idea behind the big generics such at Teva and Dr. Reddy’s attempts at patent-busting. As long as the impurities are within acceptable limits and some other potential issues (genotoxicity, for instance) are covered, it’s fine.
My generic fluoxetine (brand name Prozac) is a lot less depressing to buy than the brand stuff.
These two pages might be useful: the FDA contact sheet for the people dealing w/ different classes of generics:
And the FDA general site for generics: http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm119100.htm
In their FAQ on generics (an the other pubs I have seen, and I am not a physician or pharmacist), the FDA says there is “no difference in dosages” between brand-name and generics. However, I have heard from one of my doctors that the generic industry permits an x percent range above and below the brand name dosage (which itself is allowed some sort of range).
It has never bothered him enough–he mentioned it in passing–to insist on brand name though. I’ll ask him about it next time I see him.
Usually 2 or 3%, and I venture a WAG that it’s mostly to account for analytical error.
Certificates of Analysis for a drug product will often have dosage criteria that read 100.0 +/1 2.0%, so if your HPLC results all come back with an average of 101.3% you’re good but 97.9% is out of specification. I seem to recall generics often having to be 100% of the brand name +/- 3% but it’s been a long time and I didn’t do a lot of work specifically comparing the generic formulation to the brand name one. Once the generic is made, however, the same dosage criteria applies in quality control labs in order to get the product out the door (100.0 +/- 2.0% for example).
Impurities/degradation products might vary due to the differences in the API synthesis, and their acceptance criteria are modified accordingly. Acceptance for Impurity X-1 might be No More Than 0.2% for one company’s drug, but it might not be present enough in another’s to warrant it’s own criteria and so it would lump into the “all others, NMT 0.5%” for example.
Cool info, although the spread seems a lot to me.
More important, what’s a WAG?
HPLC = High Performance Liquid Chromatography (also called High Pressure Liquid Chromatography)
WAG= wild a** guess
Are your percentages referring to the concentrations of active ingredient in the dosage form (tablet, capsule, etc), or are they referring to the blood levels of API (Active Pharmaceutical Ingredient, .i.e. the drug itself) and active metabolites produced after administration of the drug to humans? Or both? Or none of the above? (The parentheticals for “dosage form” and “API” are just to explain jargon; I know that you know what those are).