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    Old 04-08-2008, 07:58 PM   #1
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    Brand vs Generic- Major Findings

    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

    Last edited by Executor; 04-08-2008 at 08:34 PM. Reason: Added text

     
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    Old 04-08-2008, 08:14 PM   #2
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    Angry Re: Brand vs Generic- Major Findings

    Executor,

    Thanks for doing all the research. I'm like you, when I had fairly considerable differences in pain control I just figured I was having good or bad days. My husband would ask me if it was possible to get a "bad" patch and I said of course not. Looking back I know of specific times where I was doing really well then opened a new box of patches and went down hill. I'm glad to know what's really going on and from now on it's Brand for me!

    Thanks again,
    Melissa

     
    Old 04-08-2008, 08:15 PM   #3
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    Re: Brand vs Generic- Major Findings

    Ex: I really have to thank you for this. I used to think I was insane or something. When I was taking generic Oxy, I would comment to my husband, some months, that I was sure that sometimes I was getting a "dud" or "bad" batch of meds. I would take them as usual, but would get far less relief and even mild w/d symptoms.

    I thought about saying something to the pharmacy several times, but was afraid they would think I was either totally nuts or was accusing them of some sort of foul play. So, I just kept it pretty much to myself.

    This finding explains a lot! Now I know it wasn't just me! Thank you so much for taking the time and making the effort to get to the bottom of this!

    Again, thank you for helping me verify that I'm not totally nuts. cmpgirl

     
    Old 04-08-2008, 08:18 PM   #4
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    Re: Brand vs Generic- Major Findings

    Glad to help as I'm a firm believer that a high tide raises all boats!

    For one who is on the 50Mcg patch for example, it can be anywhere from 40 to 60 Mcg....Within the same box. If you're on 40Mg Oxycontin generic, it can be in a range of 32 to 48Mg. Quite a window.

    One could provide examples galore.

    Last edited by Executor; 04-08-2008 at 08:21 PM. Reason: spelling

     
    Old 04-08-2008, 08:22 PM   #5
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    Re: Brand vs Generic- Major Findings

    Shore used to always say...If you notice heart surgeons and transplant docs don't put their patients generic.or something to that effect.

    The other day I went to pick up my husbands pain meds. I thought he got brand for both so I asked for brand and for some reason his percocet was $30. Our brand copay is $15. I still need to check that out.

    Always get brand if you can afford it...and even if you can't because we rely on these drugs to LIVE! Take care.
    Thanks for doing the work EX!
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    Last edited by trowftd3; 04-09-2008 at 07:33 AM. Reason: duh had my words backwards....sorry.

     
    Old 04-08-2008, 09:24 PM   #6
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    Re: Brand vs Generic- Major Findings

    I have noticed that when taking my oxy too. Right now I am on a good batch!! (Its brand name!!)

    Last edited by ms_west; 04-08-2008 at 09:25 PM.

     
    Old 04-08-2008, 11:12 PM   #7
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    Re: Brand vs Generic- Major Findings

    I think we must be careful to realize that every manufacturing process is prone to variances in the end product. Even those involved in producing brand name drugs.

    All throughout a manufacturing process there are allowable tolerances in both product quality and the devices measuring quality (or purity) levels. Equipment falls out of calibration regularly, and there are procedures in place to prevent and correct defects, but all production lines suffer variances in quality. Brand name manufacturers are just as dependent on the quality of bulk, raw materials as are the makers of generic drugs.

    The point is that this isn't a good guys/bad guys thing with the makers of brand drugs in white hats and the generics in black. They're all in business to make money, and all suffer the same basic challenges. That the generics are allowed the +-20% is outrageous, and we have Ex to thank for bringing this to light. But we shouldn't be too quick to put brand manufacturers on a pedastel. I wouldn't be at all surprised to learn that there's likely a wider allowable variance in their purity batch to batch than we'd like to believe.

    I can't afford for all my drugs to be brand. Even if I get my doc to write DAW on my script I still have to pay the higher copay. What I do is settle on the 'best' of the generics and stick with them. Endo makes my MS Contin generic and they do a fine job. I didn't even know how good they were until my pharmacy switched from Ethex to Endo - what a surprise! It felt like my dose had been raised.

    I believe there are good generics out there, and I intend to use them as often as possible. I believe it's a bit extreme to attribute the majority of our 'off' days to the generics.

    steve

     
    Old 04-09-2008, 03:14 AM   #8
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    Re: Brand vs Generic- Major Findings

    Steve makes a good point, That vairiance is there because it's also exceptable in brand name products by the FDA. If you give a 100 different people at the same weight, the same dose you will see the same variances. These are exceptable variances within any product do to several factors, age, metabolism, sex, even race have an effect on some drugs. My problem is when one company is constantly inferrior. My wife was in the retail pharma biz for several years and pharmies are paid a bonis to maintain a certain percentage of generic sales due to the high profit margin, we may save 30% on a generic but the retailer is making double the profit and pharmies are rewarded financially for telling every customer that their generics are equivelant and meet the highest FDA standards, which they do.

    Anyway, I read that info in AARP 10 years ago, I'm not that old but the younger folks may actually be able to learn something from folks that remeber the days when percocet was only drug dispensed for post op pain, CP wasn't treated with opiates and there was no such thing as a 10 mg Percocet, Oxycontin or Duragesic.

    BTW. The generic version of OxyC was removed for the third time in 10 years because Purdue reformulated the contin sytem at the request of the FDA when looking for a more abuse resistant version. Equally important to Purdue, they maintain a monopoly on LA oxycodone after 12 years. They now use the Acro Contin system which works closer to the way Exec described as far as smoother more continous release rather than the old double release or dual phasic. Because the generics were modeled after the old delivery system, they aren't truley an equivelant product and have the same flaws that the original name brand formulation had.This is why Purdue won their case again, along with Billions in campaign contibutions in the last 10 years and more lobbying power than tobaco, guns and alcohol combined.

    Thanks for verifying that for us Exec. Good luck with your research.
    Dave

    Last edited by Shoreline; 04-09-2008 at 03:18 AM. Reason: spelling

     
    Old 04-09-2008, 04:35 AM   #9
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    Re: Brand vs Generic- Major Findings

    i have noticed a huge difference in the synthroid meds and found i could not take generic syn thyroid at all. Had to fight insurance company and ended up finding stores that sell the brand name cheaper. But i also have had allergic reactions to certain meds lately. More so then before.
    My latest severe reaction was Watson which was doctor document as well. Part of the issue which may or may not have been stated ANYWHERE is folks do not go in when they have a severe reaction and get it documented. Or they go in and the doc is TOO busy to document it and send it in. This last bad reaction ( last week) i not only had the doctor fill out the bad reaction report right in front of me, but the pharmacists became aware of the severe allergic reaction too.
    So there is a food chain , that is suppose to be followed. I am beginning to wonder after your research is part of the problem is folks reporting it and doctors/pharmacies not following through with reporting it to FDA because of revenue /gifts given to docs from various drug companies?

     
    Old 04-09-2008, 08:42 AM   #10
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    Re: Brand vs Generic- Major Findings

    Hey Exec, My brother was qualtiy control for bayers special blood products so I sent him a 10 mg Methdose tablet to annalyze after having gone through withdawal for the second time whan I was given that brand from the pharamcy, The 10 mg tablet came back as having 8.2 mgs of actual methadone in the tablet. I complained to the FDA, the FDA directed me to Mallinkrodt, the manufacturer of methadose. I contacted mallinkrodt with the contact info I was given by the FDA and was directed to mallinkrodts PR division where I was politely told that all their products meet or exceed the highest standards and all carry the highest AB rating as set forth by the by the FDA. I basically reported them to the authorities and then was directed to the public relations dept of that company just in case they felt like policing themself. The entire experience was a big joke.

    There are alot of problems, It's not just bush, Hilary C collected more money from pharamcuetical lobbyist for this campaign than all the other candidates combined. She had a big part in the medicare part D push however the govt decided not to negotiate prices with any pharamcuetical company on medicares' behalf? Why? Obviously this isn't a political forum, but it's hardly one party or administrtation that has gotten fat from the incrediable profits made in this buisness.

    People get mad about a 10% mark up on the car they buy,when they ought to be mad about the 500,000% markup from a kilo of bulk alprozolam to a bottle of 100 1 mg Xanax tablets on the shelf. Yes, a half million percent markup. That came from another AARP newslettter that listed the top fifty drugs and their markup from a kilo of pure drug to the time it hits the pharamcy shelf. From pennies a kilo to a buck a pill for name brand. The lowest drug on that list was around 5,000% gross mark-up from kilo to shelf. What other industry works on this kind of gross margin?

    More tidbits to ponder
    Dave

    Last edited by Shoreline; 04-09-2008 at 09:30 AM.

     
    Old 04-09-2008, 09:01 AM   #11
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    Re: Brand vs Generic- Major Findings

    great info ex,really. we found out the hard way back in 2000 when my son was given a different generic prednisone that was not the one he had been stabilized on and he almost lost his "new' liver. from what his transplant surgeon told me about the so called generic "equivalent" back then really kind of scared the crap outta me. there can be that leeway you mentioned and can even go as high as 110% OVER ,yes you can also be overdosed, that active ingedient amount. i was stunned that just being given a different generic than the one my son was started and had been on for like months(almost a full year with no issues) could actully be different enough to start the rejection process in him. when they checked his pred levels there was actually 20% LESS in his system than there should have been and what had been stable with the other brand. this was one really sick way to find this out. honestly. but that was my first introduction into the world of the alleged generic equivalents. it almost cost us our child.

    in the types of meds that have whats called a narrow thereputic index,these are the transplant meds,and anti seizure meds,and blood thinners like coumadin,the ones where the dosages just HAVE to be right on target every single time or an event will occur? that is where the generics really cause the most problems and or death in some cases. they just have to be that exacting. these patients are the ones who suffer the most from this and its just a really sick thing to do to a person.

    if you have ever gotten your hands on a copy of the best of the peoples pharmacy it is a really in depth read on what the so called generic equivalents are all about. these people used to actually advocate the use of the generics til they started getting mail from people who were experincing amazingly sick repercussions in using them. there is a chapter in that book that details their 'mission" to find out the real truth from asking all the right questions from all the right people,some who worked in these drug companies. now,there thinking is totally the opposite after finding out the actual truths of the generics.

    they also mentioned just how many different hands our drugs go thru as compared to canada,and how much safer the canadian system is than in the US,just because the canadian system has many many less distributors. its just really a very scarey world out there in our US system.

    what really should make everyone sick is the FDA has known about the so called generic equivalent since the beginning and condones it. great info there ex and of course shore. good to hear from you dave. missed ya. marcia
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    Old 04-09-2008, 11:17 AM   #12
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    Re: Brand vs Generic- Major Findings

    Executor-
    Thank you for the hard work in doing a deep and thorough study about this. I had always heard and read that there was an allowable variance in the generics and never really thought that much about it until my pharmacy switched from Watson to Mallinkrodt with one of my meds.

    The Watson was great and never seemed to bounce up and down as far as effectiveness, BUT when this pharmacy merged with another large chain pharmacy, I noticed the pills looked totally different. After looking, I found that instead of Watson, it was Mallindrodt. I called the pharmacy and was told that this is the version they will carry from now on. I asked if they could order the Watson for me and was told no.

    My honest opinion about the Mallinkrodt is that it's FAR inferior, and I never know how well they will work. Sometimes they seem ok, and then other times the entire month is bad for me as far as pain levels remaining "consistant".

    I think I'll talk with my PM doctor at my appointment in May and ask him about making all of my meds "Name brand medically necessary" from now on. He does that with some of my meds already, so he should be ok with this. It will certainly be worth the extra money to know I'm not getting medications that have so much room for variances.

    Thanks again! You've given us all something to seriously think about here.

     
    Old 04-09-2008, 12:19 PM   #13
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    Re: Brand vs Generic- Major Findings

    Quote:
    Originally Posted by Shoreline View Post
    I contacted mallinkrodt with the contact info I was given by the FDA and was directed to mallinkrodts PR division where I was politely told that all their products meet or exceed the highest standards and all carry the highest AB rating as set forth by the by the FDA.

    Shore- Great Story! Thanks for sharing. This is just another example that validates what we're all talking about. Kinda interesting that they would come back with "meet or exceed the highest standards" B.S. I guess technically they do, because @ 8.2Mg, they are only 18% off, so they exceed the 20% standard!

    Amazing isn't it?

    Ex

     
    Old 04-09-2008, 12:22 PM   #14
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    Re: Brand vs Generic- Major Findings

    Quote:
    Originally Posted by ozzybug View Post
    I called the pharmacy and was told that this is the version they will carry from now on. I asked if they could order the Watson for me and was told no.
    If your Doc won't write "DAW" or "medically necessary" then maybe you could try and independent pharmacy. I have found the independent guys to be much more customer service driven. Hopefully though, your Doc will help you.

    Speaking of which, I think it's critical to all who go this route to make sure you let the Doc you know about the -20% law....This should convince him/her that you've done your homework and can't be B.S.'d.

    Going brand may not solve all your problems, but at the very least, you get more consistent meds.

    Ex

     
    Old 04-09-2008, 12:25 PM   #15
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    Re: Brand vs Generic- Major Findings

    Quote:
    Originally Posted by feelbad View Post
    great info ex,really. we found out the hard way back in 2000 when my son was given a different generic prednisone that was not the one he had been stabilized on and he almost lost his "new' liver. from what his transplant surgeon told me about the so called generic "equivalent" back then really kind of scared the crap outta me. there can be that leeway you mentioned and can even go as high as 110% OVER ,yes you can also be overdosed, that active ingedient amount. i was stunned that just being given a different generic than the one my son was started and had been on for like months(almost a full year with no issues) could actully be different enough to start the rejection process in him. when they checked his pred levels there was actually 20% LESS in his system than there should have been and what had been stable with the other brand. this was one really sick way to find this out. honestly. but that was my first introduction into the world of the alleged generic equivalents. it almost cost us our child.

    Sooo sorry Marcia to hear about this, but I very much appreciate you sharing because every story lends more credibility to the situation. Also, the way I read the law, you can go as much as 20% over, or 120%.

    Ex

     
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