Are generic drugs as effective as name brands?

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.

I did say * used to*. Not a good analogy * any longer * might have hit it better, though. I’ll try to be clearer.

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.

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.

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.

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.

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.

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.

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?

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 :slight_smile: ).