Executor

Well folks, I've got some real stunning news for you....May surprise some, maybe not others. Some of you know I've been on the +/-15% thing for a while....Doing research & etc. I've talked to my pharmacist & Doc, among many others. I have hit this topic HARD, spending much of my free time on research. I've gotten very close, but couldn't quite put my finger on that last piece of research that cemented things firmly.

Well.....Today, I hit the mother load. I ran into an old friend who is now a pharmaceutical rep....Sells blood pressure meds & anti-depressants to GPs. He unlocked the holly grail for me and linked everything together. I asked him about this concept and he verified it 100%. He said that across the board, generics can be +/- 20%. He provided written information to me via e-mail and I've studied this over & over. Since we can't cut & paste, here is my translation in my own words:

Current FDA regulations permit a variation of up to 20% either way in the bioavailability of the active and inactive ingredient, 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 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%) every time in order to cut costs and improve contribution margin due to the low market price.

Thus, this 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 board and talk about all our problems, I'm willing to bet most 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 as we've discussed), you could be getting radically different drugs.

For me, I've spent tens of hours upon hours researching the fentanyl patch. 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 is due to the +/- 20% variation permitted by the FDA. For example, this 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.

My rep friend told me that this is a very controversial subject within the pharmaceutical industry that the big 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 make so much sense now! I realize the co-pays & etc. can get pricey, 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.

Hope this helps.

Ex