Young Professor
05-16-2008, 09:45 PM
I posted a lot of this in the Fentanyl section in response to a question on which patches were best....But, I thought I would re-post some of it here in order to get more exposure....I've learned a lot lately, and thought I would share it with everyone, especially those with chronic pain. I'm not here to judge anyone, but rather learn myself and help others where possible. Please feel free to provide any feedback.
Many have either stated or speculated that they can tell a difference between brand name meds and generics. The reason for this is because it's true. Current FDA regulations permit a variation of up to +/- 20% in the active and inactive ingredient of generics, according to Hatch-Waxman Act of 1999. In one study (Borgheini 2003), a 31% variation was found in the blood plasma levels of a particular medication after a patient switched from a branded to a generic product. Why does this happen? It is accounted for by differences in the manufacturing process yielding different ingredient qtys that are absorbed at different rates, as well as other factors. Some companies change the inactive ingredients, while others constantly change suppliers of raw material (drug compounds) in order to cut cost. I can assure you that a well run profit oriented drug company will be "under" (-20%) most of the time in order to cut costs and improve contribution margin due to the low market price.
The Hatch-Waxman Act of 1999 gives them a leeway of 40% (-20 to +20) on both active and inactive ingredients on manufacturing these drugs. They can be significantly different than their name brand counterparts, and in some cases the effect can mean a drug doesn't work at all, or may have too much of the active ingredient, resulting in serious effects or even fatalities! Generics are not equal to brands, and in fact, are far from it!
So, as we all come on this site (and other boards) and talk about all our problems, I'm willing to bet many of the issues can be traced back to generics. Now....You may say "well, I've always been on generics".......Ok....BUT....Since the FDA gives them a 20% variation in each direction, that means generic vs generic, batch to batch, and even pill to pill (or patch to patch), you could be getting radically different drugs.
For me, I've spent tens of hours upon hours researching the fentanyl patch.:puterwork I can pinpoint at least 100 testimonials (many on this board that are current as well as dated) that talk about how Mylan is much better than Sandoz while others swear Sandoz is better than Mylan. The feedback is pretty much 50/50. How the feedback be that erratic?
I've come to the conclusion that the wide variance in findings and testimonials are due to the +/- 20% variation permitted by the FDA. For example, one batch of Mylan may be right on target, the next batch weak, the next batch strong, and so on. The same goes for other brands, thus, accounting for the wide variance. I'll go as far to say that some patches in a box are different than other patches....I've experienced this myself and thought that I was just having a bad day. I've also read many, many testimonials where others have said the same thing...I have to admit, I thought they were crazy at first.
I was tipped off by a friend of mine who is a drug rep. Once he pointed me in the right direction, I researched it from there. Additionally, he told me that this is a very controversial subject within the pharmaceutical industry and that the big brand companies are trying to lobby the Gov't to change. His exact comment was "you know...for allergy medicine it may be alright to be off by 20%, but for blood pressure meds, it could kill you." I didn't tell him about my PM history, but the whole time he's providing me with this valuable information, I'm thinking.....Holly Cow.....What if my patches, or BT meds are varying by +/- 20% or 40% total...No wonder I have good days and bad days!!!
My conclusion.....I'm going to brand immediately and as long as I can afford such, I'm not wavering. My whole life depends on these meds and I'm not going to allow this variation to run my life. Everything makes so much sense now! I realize the co-pays & etc. can get pricey for brands, but to me, I can't afford not to. One suggestion I have....Pressure your Doc to write "DAW"...Dispense as Written on the script or "Brand name medically necessary"....Most policies will cover it and charge you the generic co-pay. Explain to your Doc that you've learned about this 20% thing and that the wide variation is affecting your health. At the very least, you'll have more consistent dosing of whatever med you take.
Sorry this got so long, but I figured I really need to explain what was going on scientifically.:cool:
YP
Many have either stated or speculated that they can tell a difference between brand name meds and generics. The reason for this is because it's true. Current FDA regulations permit a variation of up to +/- 20% in the active and inactive ingredient of generics, according to Hatch-Waxman Act of 1999. In one study (Borgheini 2003), a 31% variation was found in the blood plasma levels of a particular medication after a patient switched from a branded to a generic product. Why does this happen? It is accounted for by differences in the manufacturing process yielding different ingredient qtys that are absorbed at different rates, as well as other factors. Some companies change the inactive ingredients, while others constantly change suppliers of raw material (drug compounds) in order to cut cost. I can assure you that a well run profit oriented drug company will be "under" (-20%) most of the time in order to cut costs and improve contribution margin due to the low market price.
The Hatch-Waxman Act of 1999 gives them a leeway of 40% (-20 to +20) on both active and inactive ingredients on manufacturing these drugs. They can be significantly different than their name brand counterparts, and in some cases the effect can mean a drug doesn't work at all, or may have too much of the active ingredient, resulting in serious effects or even fatalities! Generics are not equal to brands, and in fact, are far from it!
So, as we all come on this site (and other boards) and talk about all our problems, I'm willing to bet many of the issues can be traced back to generics. Now....You may say "well, I've always been on generics".......Ok....BUT....Since the FDA gives them a 20% variation in each direction, that means generic vs generic, batch to batch, and even pill to pill (or patch to patch), you could be getting radically different drugs.
For me, I've spent tens of hours upon hours researching the fentanyl patch.:puterwork I can pinpoint at least 100 testimonials (many on this board that are current as well as dated) that talk about how Mylan is much better than Sandoz while others swear Sandoz is better than Mylan. The feedback is pretty much 50/50. How the feedback be that erratic?
I've come to the conclusion that the wide variance in findings and testimonials are due to the +/- 20% variation permitted by the FDA. For example, one batch of Mylan may be right on target, the next batch weak, the next batch strong, and so on. The same goes for other brands, thus, accounting for the wide variance. I'll go as far to say that some patches in a box are different than other patches....I've experienced this myself and thought that I was just having a bad day. I've also read many, many testimonials where others have said the same thing...I have to admit, I thought they were crazy at first.
I was tipped off by a friend of mine who is a drug rep. Once he pointed me in the right direction, I researched it from there. Additionally, he told me that this is a very controversial subject within the pharmaceutical industry and that the big brand companies are trying to lobby the Gov't to change. His exact comment was "you know...for allergy medicine it may be alright to be off by 20%, but for blood pressure meds, it could kill you." I didn't tell him about my PM history, but the whole time he's providing me with this valuable information, I'm thinking.....Holly Cow.....What if my patches, or BT meds are varying by +/- 20% or 40% total...No wonder I have good days and bad days!!!
My conclusion.....I'm going to brand immediately and as long as I can afford such, I'm not wavering. My whole life depends on these meds and I'm not going to allow this variation to run my life. Everything makes so much sense now! I realize the co-pays & etc. can get pricey for brands, but to me, I can't afford not to. One suggestion I have....Pressure your Doc to write "DAW"...Dispense as Written on the script or "Brand name medically necessary"....Most policies will cover it and charge you the generic co-pay. Explain to your Doc that you've learned about this 20% thing and that the wide variation is affecting your health. At the very least, you'll have more consistent dosing of whatever med you take.
Sorry this got so long, but I figured I really need to explain what was going on scientifically.:cool:
YP