OK. Generic drugs are by definition bio-equivalent to the name brand drugs, and they cost less. So, why would ANYONE want name brand drugs (assuming generics are available)? Is it all about the feeling that one is getting the best money can buy? Do they not know better? Do they like paying for the advertising?
Or is it something like the insurance companies are subsidizing the name brands, by not paying for generics?
Vis
IIRC, generic’s aren’t an exact copy. Close, but not quite. I’ve had cases where the Doctor, when asked about generics, would say “Normally I would, but the generic in this case doesn’t work as well.”
Generics are often as good as the original, and certainly much cheaper. The original drugs tend to be better studied, and this clinical experience is valuable in toxic drugs with a low “therapeutic index”.
When a 5 mg tablet is prescribed, in practice the actual pill will be within a certain tolerance of 5 mg, not the exact number. In some cases, this tolerance is bigger for generic pills but this usually doesn’t make a difference.
In most cases, name brand drugs are available in a wider range of doses. This is sometimes useful, i.e. with warfarin vs. the new generic. People don’t like taking several pills, and understandably so. Not all are equally compliant with medication.
Some countries manufacture better generic drugs than others. On the other hand, in India you can buy an asthma puffer on the street for five rupees.
Drug companies spend lots of money treating doctors to food and golf to keep their name brand in view. They provide samples and expert advice to doctors. This can be very helpful but too cozy a relationship may affect patient care. What drug are you talking about?
Surprisingly, a different side effect profile is occasionally seen in drugs from different companies!
In many cases, the brand-name drug is little or no different from the generic, and there is no good clinical reason to prescribe the more expensive drug over the cheaper one.
In some cases, there is a real difference, albeit small. For example, many epileptics will have an adverse reaction to a switch from one brand to another even if the active ingredient and dose are technically the same. If this produces only one tonic-clonic seizure, it’s enough for the person to lose his driving license, so many doctors will be very reluctant to switch a patient to a cheaper brand (or generic) version of the same drug. The same is true, to a lesser extent, with diabetics and insulin.
As for other cases, there are a few reasons; some good and some bad:
Time pressure/lazyness: the doctor might remember the brand name but not the generic name. For example, Betamethasone Valerate is marketed (in the UK) as “Betnovate”. It’s commonly use for eczema and similar skin diseases and most doctors (that I know) remember “Betnovate” much more easily than the generic name. Add an extra couple of quid to your prescription cost.
Marketing: In my household we have approximately 64 items which bear the brand name of one drug or another. I recently wrote a note to our neighbour on paper that said “Endocort Enema” and thought nothing of it. Funnily enough, none of these things carry the generic name of the medecine.
Beanz Meanz Heinz: As a general rule, Glaxo’s own brand drug is at least going to be of reliable quality and, from time to time, you’ll find that Bloggs brand comes up with a dodgy batch. Why buy Coke or Pepsi rather than supermarket own brand drink? It’s the same reasoning: you’re getting a quality product from an established manufacturer.
Compliance: Many patients, when asked what medicines they take, say somethig like “pink ones in the morning and yellow ones at night.” Given the potential confusion it could cause, you don’t want to try to switch them to green ones in the morning and blue ones at night unless there’s some pretty big clinical benefit. (Why were they started on the brand-name drugs? See time pressure/lazyness & marketing.)
Evidence: Like Dr_Paprika says, the major clinical trial might have been conducted with brand X but not brand Y. There may or may not be a significant (undiscovered) difference in effectiveness between the two. Drug advertisements often play on this: “the only drug proven to increase five-year survival post-MI” and so on. We’re back to the “Brand X” factor.
There might be a liability issue as well for the issuing doctor (at least that’s my guess).
God forbid a doctor prescribe a generic (that has by definition not been on the market as long as the name brand drug) and there is a problem, you know the doctor will get his ass sued because he COULD have prescribed the branded drug but chose not too.
Another guess I have in this arena is that the same drug is sometimes prescribed for multiple indications and if you have some new disease where it is applicable (i.e. especially an off-label use), I think the doctors are required to use the branded drug rather than the generic for legal reasons.
There seems to be a little confusion about what a generic drug is. A generic equivilant contains the same active ingredient as the name brand drug. A good OTC example is Tylenol/acetominofen. Anyone can make acetominofen (the molecule that stops the pain) and put it in their analgesics. But only Tylenol can call it “Tylenol”.
And to be considered a generic equilivant, one of the specs it must meet is for a given theraputic dosage to achieve a blood serum level +/- 30% of what the original drug does. That’s quite a wide target. Makes it really easy for other drug companies to manufacture generics.
Does it matter much? Depends on a lot of things, I guess. If I was dependant on daily medication and my well-being took a 30% nose dive, I’d be raising hell with my insurance company for insisting on generics.
Now comes the real scam - I don’t know if it’s legal or if it’s being done (I don’t see why not) - but a drug manufacturer could take their flagship drug, make the pills 30% smaller, and market the generic equivilant at 25% lower cost. Reaping a greater profit margin than the original.
[sub]I’m in the wrong business.[/sub]
Honky, yours is the most intelligent post in the thread, congratilations. I’ve never heard/read about this ±30% requirement. Who requires this? The FDA? Are you sure that they require company Aa to standardize a drud to the product made under an expired product by company Bb? The generic product, by definition, is the same as the chemical in the brand name preparation, just having no name (or sold unfer its chemical/common name), the same under which it is known in the USP and which should be always nentioned with the brand name (Tylenol/acetaminofen). Manufacturers are allowed to add emulcifiers, detergents, etc, which may slightly change the propertieis of the original chemical, by not by 30%. 30% change in bioavailability makes it a different drug.
Finally, the last paragraph. Usually there is almost no price difference for various doses. A 20mg tablets may be 10% more expensive than 10mg tablets. The amount of medication does not make much difference and influences very little the cost, even less the price.
I’ve heard from two doctors, independently, that Synthroid was an example of a drug where the generic was not recommended. I don’t take it myself, so I don’t know if it was a quality issue or what, but I seem to recall something in the news about this particular drug as well.
Buying name brand drug instead of a generic is a little like buying a Compaq or Dell or IBM instead of a plain vanilla PC (or buying gas from Shell instead of Starvin Marvin), you are paying for advertising, the name, and (you hope and would like to believe) a tiny edge on quality. Except that the savings attainable by buying a plain vanilla PC instead of a name brand are small whereas the savings when buying generics instead of name brands can be very large. As for significant differences between name brand drugs and generics, they exist mainly in the minds of name brand sales reps. It rarely happens that there is any clinically significant difference between a brand name and a generic and the chance of getting a defective generic is about the same as getting a defective brand name product.
What you have to remember is that for many purposes, the dose of a drug that you get does not have to be at all precise. You can often take half as much, or twice as much, or five times as much and still get the effect you want without any increase in side effects. (Did you ever notice that for most drugs, the same dosage is prescribed for 97 lb women and for 275 lb men?) That’s why plus or minus 30% is usually of no clinical importance. There are a few drugs which must be given in precise doses but they are the exception.
Yeah, you are on the right track about doses, but exagerate. Besides “exceptions” there are drugs with a norrow therapeutic range, druds prescribed for children, and some other situations, like in cancer chemotherapy. Usually, if there are druds dosed as 5mg, 7.5mg, 10mg, etc., there is a good reason for it. Yor better take the prescribed dose.
Your beginning examples are totally irrelevant: all computers are different, even if assembled of the same parts (which is never the case).
This is the situation: a compound is called acetylsalicylic acid. This is the name under which it is listed in the U.S.Pharmacopeia (the oficial compendium of all drugs). It can be sold (a)under its own name, in pure form or with added “inactive” incredients, as (b)Bayer Aspirin (same chemical with a set of "inactive ingredients) or as ©Shmeyer Aspiryn (as above, the “inactive” ingredients may be the same as in (a) or (b), or be a different proprietary set.
Usually, but not necessaryly, (a) is sold as “generic”. Under the chical/common name, without advertizing, etc. In ~98% there is no difference in “active” ingredient (actually, by law a drug must not differ from that filed with the FDA. It is filed as “Bayer Aspirin/acetylsalicilic acid”. So the FDA and everybody else knows what chemical is concerned). Rarely, two versions of the same chemical exist: a “natural” one and a (semi)synthetic one. They are supposed to be, and usually are, the same. All natural ones are l- stereoisomers, synthetic ones may be a mixture of l- and d- stereoisomeres. In a few cases, that may mean, that the dose of the synthetic drug should be increased, to compensate for the content of l- stereoisomere(if d- is inactive; this may or may not be the case). But in such cases the FDA introduces the appropriate corrections. Some doctors may believe that a (cheaper) synthetic version ain’t as good as natural one, and would not prescribed it. As you understand, the original manufacturer does its best to convince the doctor.
I agree with most of what has been said. With a few quibbling exceptions.
With respect, it does not. Generic companies are allowed a wider range of tolerances, but this is still a bell curve centred on the reported dose. In many cases, the physical effect of the drug would be the same regardless of this difference, although 30% is surprisingly large. What is the range for non-generic drugs? It has to be bigger than 10%, is it as high as 20%? If the drug is taken several times a day and/or over a period of time, these differences will balance out. Effective doses for many drugs are constantly revised, doctors now use lower doses of beta-blockers and ACE inhibitors to get most of the effect without quite so many side effects.
This is a good point, but it really depends on how dangerous the drug is and who is prescribing it. For kids, drugs are nearly always calculated per kg. Anaesthesiologists also tend to drug on a per kg basis. Toxic drugs, such as cancer chemotherapy, tend to be calculated both on the weight of the patient and their kidney function, as measured by creatinine clearance. Skillful doctors would not give the same dose for these different weights, but when busy it is a common trap. Drugs like Synthroid, Warfarin and Gentamicin are dosed by follow up bloodwork, of course. And these are the exception.
Looking through my book Drugs of Choice, which gives the cost of drugs in Ontario (and is published by the OMA so doctors give consumers less expensive drugs when cost is an issue), there is only some truth to this. Bigger doses do seem to cost more, but the change in cost, while significant, is far from linear with the change in dose. This could certainly be different in other places.
Finally, Tylenol is acetaminophen, of course, in the US. In several parts of the world (India, UK, etc.), this drug is called paracetamol.
I do not like to be caught on mistakes… so:
I know about bioavailability and even the fact that some druds are monitored by blood level and some are administered based og body surface.
Of course, different bioavalability does not make a different drug, it’s still the same drug, but acting differently. Bioavailability itself exists only in the body, not in the container, and depends more on the body, than on the drug.
Q:Generic companies are allowed a wider range of tolerances
Are you sure that there are different set of laws for generic companies and other companies? Often, generic drugs are made on the same line, just packaged in different containers.
I don’t know if there are different laws for generics. Quite possibly not. But several companies make a point of this, i.e. duPont makes Warfarin and says their product is better than the new generics since their tolerance is 10% and Apotex is within 30%. They nay have changed their tolerances to make this a selling point, I don’t know.