Generic drugs not identical to brand name in function.

[lib_wit_it]

Yet drug cos are making huge profits on generics of their brand name drugs.

http://www.peoplespharmacy.com/2009/02/16/are-generic-dru/

Tod Cooperman, MD, President of ConsumerLab.com, stated that “This information shatters the myth that generics are always identical to the original and it questions the belief that generics are always equivalent. Even if the active ingredient is the same, releasing it at a different rate may alter a drug’s effects.” He added, “Generic drugs are essential to keeping medical costs down, but consumers and healthcare providers need to be aware of the potential differences among products otherwise thought to be the same. Generics are not clinically tested for safety and efficacy, so the consumer will be the first to find out if there is a problem.” ConsumerLab.com intends to publish additional reports on generic drugs on its website.

The testing was funded by ConsumerLab.com without drug company involvement. The full report is available to ConsumerLab.com subscribers at www.consumerlab.com/results/wellbutrin-bupropion.asp. The report includes test results, information about other generic versions of bupropion on the market, and a list of other popular extended-release generic drugs. The Graedons and The People’s Pharmacy® receive no financial support from pharmaceutical companies. Reports of generic drug problems by consumers are posted at www.peoplespharmacy.com.

[lib_wit_it]

1. More info:

http://www.thirdage.com/medical-care/are-generic-drugs-really-identical-to-brand-name-counterparts

"For one thing, the FDA does not require generic drugs to contain the same inactive ingredients as the brand-name products.

That means colors, binders and fillers (that often make up the majority of the pills) can be quite different. In some cases, this may mean someone is allergic to one formulation of a generic drug even though he tolerates the brand name.

Many pills are designed to release the active ingredient over a sustained period of time. Generic products may use a different formulation. This may alter the way in which the medicine gets into the bloodstream.

A few years ago, we started hearing from readers of this column that the generic drug Budeprion XL 300 was affecting them quite differently from the brand name Wellbutrin XL 300. When we investigated, we learned that the generic used a different technology to control the release of the active ingredient bupropion. This resulted in the drug getting into the bloodstream faster."

I was just switched by my plan from Wellbutrin XL 300 to the generic. We shall see if I experience any problems.

[dipsydoodle]

2. Pure and simple - I just don't believe that

other than maybe odd isolated examples.

[lib_wit_it]

3. Online meds discussion boards are full of examples. My own sister absolutely knows that her

thyroid meds in generic form don't work for her.

Did you read the articles? How could different delivery systems not make a difference? And surely inferior fillers can have negative effects.

Initial approval of the meds were based particular delivery systems and fillers. They certainly can, and often do, make a noticeable difference.

[dipsydoodle]

7. Well I've never heard any gripes here in the UK

Maybe we've got different suppliers. :shrug: If / when you've got single payer you'll have what's approved under your health service and if its generics then so be it.

[lib_wit_it]

11. Which is why I want this info out there, so that consumers are informed and can try to make sure (or

at least try to ensure)that the inferior generics are not the only option offered.

[dipsydoodle]

13. Fine.

You've got a different situation there anyway. What would actually happen here is that the NHS presciption which is c. $10 , for those eligible to pay at all , could only be raised for an NHS approved drug/compound whatever. The patient could as an alternative simply ask for and pay for a private prescription for a non NHS approved alternative - the cost of doing so would be the manufacturer's recommended retail price.

BTW - Approval or non approval by the NHS is a cost issue : they do not appreciate being ripped off. I'm sure the same would apply if you had single payer. Argue against that if you wish but in doing so you would be arguing against single payer.

[lib_wit_it]

18. Patients don't appreciate being ripped off either. I don't know exactly why, just as no one is quite

sure why getting vitamins and minerals directly from food, rather than from supplements, is more beneficial to health, but studies suggest that it most surely is. I know, my sister knows, and, as these articles suggest, we aren't alone. Some generics do not perform the same as the brand.

Regardless of the testing the FDA does, if it says there's no difference, then I say the studies are somehow faulty.

If consumers are aware that there can be differences, then we can apply pressure to fix that problem, so that when we do get single payer (hahahahahahahaha), the generics we get will be truly equivalent in functionality.

[Mariana]

20. Maybe the NHS requires that generics

have identical ingredients, both active and inactive, as the brands. Do you know if that's the case? I don't know if they do, but if so it would explain why there aren't any complaints.

[PVnRT]

15. So long as the filler/matrix/solvent is suitable for human consumption

the FDA typically doesn't delve into that part of the drug for the original submission. Everything is based on the active ingredient.

Generic companies are still required to perform clinical testing, however, I know the one I worked for used to do it over in India.

[proud2BlibKansan]

5. Oh I believe it

I've seen it too many times.

[ThomCat]

6. I'll give you a very specific example of how true this can be.

When I was getting Morphine, my pain management doctor would write on the prescription "DO NOT FILL WITH BRAND XXXXX"

Why? Because of the three manufacturers of generic morphine tablets, two of them produced tablets that worked significantly better than the third. The only difference was in the inactive ingredients. The fillers.

I'm on different painkillers now, and he still specifies which brand of each med I should get, because he knows through years of experience with all of us which brands work better and which are worse.

When 2 or more manufacturers make the same medicine they are not always going to be identical. The fillers, binders, colors, coatings, and other ingredients are going to influence the medicine. It is combined with another simple drug like tylenol or caffeine? That's going to have an effect.

That's why Brand x morphine, Brand y morphine, and Brand z morphine were not the same.

[lib_wit_it]

9. Thanks for sharing that. I've noted differences too, but I have been on so many meds

that I can't recall the specific examples, but those past examples were the reason I went looking for info on this on line, since my Wellbutrin just got downgraded to generic, and lo and behold that was one of the main examples noted.

Also I want to wish you the best possible meds to ease your pain.

[BlueIris]

4. Great info. Thanks for posting. nt

[Indy Lurker]

8. Generic Drugs are not Identical

But the generic drug manufacturers have to show that they release the active ingredients at the same rate as the name brand drug. The delivery system or time release method can vary, but the dosage must be the same per hour on a standard test.

[lib_wit_it]

10. Nevertheless...

*something* is different enough to make a difference in the effectiveness or side effects.

If the brand-name products could be produced with the cheaper ingredients and/or delivery system and produce the same results in FDA testing, wouldn't the companies use those cheaper methods and make larger profits in the first place?

[Indy Lurker]

21. Yes, something is different.

If the results are different.

In general the ingredient cost is very small, especially for the inactive ingredients.

For example, starch is around $200 per ton.

The active ingredients are for the most part identical, the delivery system would also be matched if possible. If a delivery system is different, it is most likely done in a way that is familiar to the generic company, as opposed to a way that is necessarily cheaper.

I think part of the problem is that medical science is not entirely sure how some of the psychoactive drug work, as such, it's hard to nail down the specifications.

[lib_wit_it]

12. Another source of similar info:

"I told the nurse at the travel clinic about my experience, and she made a very sharp observation. AllerClear is a generic product, and as such WE DO NOT KNOW WHERE THE FILLER IS MADE - IT COULD BE MADE IN CHINA OR INDIA!!!! She thought I had experienced a reaction to the filler. The nurse also pointed out that in order for generic drugs to be cheaper, then they will use cheaper products - such as filler. And, India and China make cheap filler.

Now that I have been educated a bit about high blood pressure, AllerClear or Claritin probably should not be taken. This post in no way meant to slander or bad-mouth Claritin or Aller Clear. The reason I'm leaving this post is to let people be aware of the hidden side effects of fillers in generic drugs. My decline was so slow and insidious that I didn't put the drug and effect together. I wrongly assumed that it was some sort of arthritic condition - after all, I was 57. I am happy to report that the only medications I take are a minimum blood pressure med, occasional ibuprofren and vitamins. I now have complete mobility and am pain free."

http://www.peoplespharmacy.com/2009/07/20/dont-let-drugs-1/

[PVnRT]

14. Ummm..generic companies may be making mad profits off of generics

The big boys, however, don't. That's why they want to expand patent protection.

Furthermore, for a generic to claim that it's the generic equivalent of Drug X, the company manufacturing it must demonstrate to the FDA that the safety, identity, strength, purity and quality (that's lifted directly from FDA's cGMP regulations) of the generic are the same as that of Drug X. Otherwise, it can't claim to be that, it would have to be marketed differently, and pharmacists would not be able to substitute it without consulting your doctor.

[Statistical]

16. All the major drug companies also make generics.

Often they will make generics of competitors and sometimes they make generics of their own product.

The idea that the big companies don't make money off generics is simply wrong.

[lib_wit_it]

17. Exactly.

[Mariana]

19. The insurance companies don't give a damn

if the generic doesn't work for you for whatever reason. My mom is allergic to the generic "equivalent" of her blood pressure med. The doctor writes her scrip for the brand only, no substitutions. Every time she tries to refill her scrip the insurance company initially refuses to pay for the brand and demands that she get the generic. Every time she has to call the insurance company and raise hell, and every time the doctor's office has to call them too and send in documentation AGAIN that she's allergic to the generic and requires the brand.

You can imagine the effect all this has on her blood pressure.

I'm still trying to figure out what they expect to accomplish by doing this. Are they trying to wear her down so she'll give up and just take the generic? It's hard to believe they're so stupid that they think she'll ever take a drug she's allergic to. Even if she did, she'd promptly land in the ER costing them MORE money than just paying for the brand.