Posted by laima on February 26, 2007, at 8:56:53
In reply to Re: Drug manufacturing and quality control, posted by notfred on February 26, 2007, at 1:19:56
Yes- I am certain manufacturing processes and other such factors must play a role. But I feel I heard the part about how they "might" in some cases use lower quality or "less pure" raw ingredients from a pretty credible source. My doctor specializes in pharmacology, and has been involved as an independent consultant for some drug studies, so knows some stuff about fda regulations and industry rumours, etc. I should be clear- he never said anything like, "generics use poor quality ingredients"- but believes it's a definate indirect possibility. (He also has no grudge against generics, and prescribes them regularly--but acknowledges that some people do detect a difference of action in some cases, and in those cases, he specifically prescribes for them the version that works better for them.) Generics get to cut costs- fda gives them permission to take measures to do this---quality of ingredients are a way of cutting costs. I mean, isn't 99cent generic supermarket butter bio-equivalent to 6$ organic guormet Danish butter? But they don't taste the same. Isn't Maxwell House coffee technically bioequivalent to Starbucks, of same varietal? But they don't taste the same, and in processing, the darker the roast, the less caffeine. Well, I don't know if these are very good analogies, but I'm not thinking of a better ones off the top of my head. I also personally note that if the fda is failing at monitoring spinach and peanut butter quality- why should I think they are closely watching what the generics are doing, unless someone complains? I picture some inspector showing up time to time to see if the place is clean and the pills are still fit for human consumption. Generics are not advertising anything- so there isn't any need to bust them for false advertising. The brand versions already supposedly proved safety...and jumped through hoops to groom their product to perfection in order to sell well and gain a following--and their products are more visible and available for scrutiny by govt and public alike. I'm sure monitoring claims in their advertisements keep the fda pretty busy...I am also sure that each generic manufacturer is different as to their ethics, their choices of how to cut costs, perhaps they use different suppliers for their raw materials, and I bet it varies from med to med. Bottom line: they have permission to cut costs, and are not under the same level of fda scrutiny as are brand name versions.The single solitary med I ever noticed a quality/action difference for between brand and generic is in the case of Barr adderall-and it was NOT a matter of potency. If Shire brand consistently felt smooth, calm, and bright-with no noticible kick-in or crash, but had modest appetite suppression effect--and Barr generic sent me through a jittery, heart-poundy phase as it suddenly "kicked in", (particularly if I hadn't eaten), had zero appetite effect, was distinctly noticeable when it wore off- and even made me feel emotionally vulnerable at that phase- and eventually just made me plain depressed no matter what the time of day---how can they be bioequivalent? One brightened my mood significantly and didn't ever feel like being on anything, the other was choppy and made me very depressed after two weeks. Like two different drugs. Adderall was designed by Shire to be smooth--and in my case it lived up to the promise quite impressively--so if the generic version loses that key quality thanks to their manufacturing techniques or "inactive fillers"--it's not the same!
And what of that thread from a while ago, where it was reported that generics can be 20% less effective than brand, legally?
> My understanding is that the variation is in bioavailability as generics must prove that they are bioequivalent to the brand. Bioavailability
> is about how well the body takes up the med. This is where the inactive ingredients come into play and manufacturing process can also matter.
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poster:laima
thread:735309
URL: http://www.dr-bob.org/babble/20070224/msgs/736381.html