![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 38 to 62 of 62. Go back in thread:
Posted by Squiggles on February 27, 2007, at 16:07:55
In reply to Re: Drug manufacturing and quality control » notfred, posted by Larry Hoover on February 27, 2007, at 15:34:48
I propose that BA is easier to botch, and get away with, as many environmental circumstances, such as storage, temperature, age an be overlooked. And I would guess that when there are problems between generics and trade variations, it is not the bioequivalence that has not passed the test but the bioavailability.
Squiggles
Posted by Larry Hoover on February 28, 2007, at 13:29:04
In reply to Re: Drug manufacturing and quality control » Larry Hoover, posted by laima on February 27, 2007, at 15:52:17
>
> Wow- I never heard that! Horrifying!Well, I debated for days, even mentioning it, for that reason. I really didn't want to stir the pot, but it's potentially very relevant to our discussion. Perhaps it's gone quiet while they investigage. Far better to have proof of due diligence up front, but that's not the way the system works.
I must frequently remind myself that the medical system was not like it is today, only a few decades ago. Different hospitals offered different treatments; there was no standardized care as we know it today. Different doctors offered different drugs for the same maladies, or did experiments on patients without any real oversight. Drug companies passed no muster before offering up a new treatment. Snake oil was literally available.
We're trying to forge an entirely new system of oversight, while still functioning with all kinds of unexamined remnants of the past. There are bound to be failures, whether due to fraud or simple human frailty. Anybody remember the "ulcer diet"? Who knew that a simple course of antibiotics would be the cure.
I've drifted off track, haven't I?
I think one of the problems with generic drugs is that there is so much money flowing into that area of manufacturing that there are bound to be start-up problems. Quality control can be measured in so many different ways, yet only the end consumers' experiences are really relevant. If we make our collective voices heard, maybe we'll make a difference? E.g., if nobody wants Barr's IM dexedrine, surely they're going to be affected by cash flow issues? Eventually? <hoping>
Lar
Posted by Squiggles on February 28, 2007, at 16:57:28
In reply to Re: Drug manufacturing and quality control » laima, posted by Larry Hoover on February 28, 2007, at 13:29:04
Are you suggesting that we should boycott
generics?
Posted by Larry Hoover on February 28, 2007, at 17:14:37
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 16:57:28
> Are you suggesting that we should boycott
> generics?No. Only ones that don't work right.
Lar
Posted by Squiggles on February 28, 2007, at 17:15:59
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by Larry Hoover on February 28, 2007, at 17:14:37
Ha ha ha ha!!! Good one:-)
Squiggles
Posted by laima on February 28, 2007, at 18:28:25
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 17:15:59
But I'd agree!
And I'm sure not all generic manufacturers are the same in their ethics or quality.
I'm personally feeling kind of down on Barr right now: I found their generic version of adderall to be unpredictable and ultimately quite harmful to my mood- and noticed on ADD boards that many people reported complaints about this particular generic that were identical to my own. Same bad effects. Of course, a few people like it- but I thought generics were supposed to be cheaper but identical equivalents to the originals, not behave like altogether distinct meds themselves? I thought the idea was that generics were supposed to be directly interchangeable with the brand versions? That's what all the notices posted around the pharmacies claim. I also find it peculiar that Barr went to the trouble to aquire the Shire original, and is now offering two versions of this medication, when their own generic version was supposedly identical to the original in the first place. And to top it off, they are currently suing Shire to give up the patent to Adderall XR several years early-claiming Shire has a monopoly on it. (Um- Shire invented it...) What's up with that, ethically? Let me guess- then next they will try to buy Shire's original Adderall XR, too? Will Shire then eventually give up developing newer, better meds if generic companies start a habit of suing them out of their patents? I mean, they can't develop drugs for free out of the goodness of their hearts, unfortunately- it has to be profitable- they need an incentive. Govt. doesn't seem interested in funding new drug development, as far as I can tell. So for the time being, I think we are stuck with capitalism. And where I live, pharmacy choices are basically Walgreens or CVS- with a sprinkling of Domonick's/Safeway. Lucky me, my drug coverage is tied to Walgreens. I don't even know of any independent pharmacy anymore. Walgreen's only generic version of adderall is Barr. One Walgreens in fact told me that they have an exclusive contract with Barr for generic "adderall". It's Barr or brand- and brand is now Barr, too. I'm starting to feel like my choices are Barr, Barr, Barr. And it doesn't work for me! And this generic version is no bargain for me or for anyone else who does poorly with it. I feel like the original Shire version worked great for me, and thanks to the generic company's takeover, it appears, feels to be gone. Choices shrunk. Ironically, it's the generic company here that seems to have the real monopoly on "adderalI". I don't like this situation at all.
> Ha ha ha ha!!! Good one:-)
>
> Squiggles
Posted by Squiggles on February 28, 2007, at 18:53:18
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 18:28:25
Frequently Asked Questions about Generic Drugs
1. What are generic drugs?
2. Are generic drugs as safe as brand-name drugs?
3. Are generic drugs as strong as brand-name drugs?
4. Do generic drugs take longer to work in the body?
5. Why are generic drugs less expensive?
6. Are brand-name drugs made in more modern facilities than generic drugs?
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
8. Does every brand-name drug have a generic counterpart?
9. What is the best source of information about generic drugs?1. What are generic drugs?
A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
back to top
2. Are generic drugs as safe as brand-name drugs?
Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
back to top
3. Are generic drugs as strong as brand-name drugs?
Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
back to top
4. Do generic drugs take longer to work in the body?
No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
back to top
5. Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.
back to top
6. Are brand-name drugs made in more modern facilities than generic drugs?
No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
back to top
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
back to top
8. Does every brand-name drug have a generic counterpart?
No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
back to top
9. What is the best source of information about generic drugs?
Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.
Consumer Education: Generic Drugs
Posted by laima on February 28, 2007, at 18:57:11
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 18:53:18
Oh yes- I've seen this notice at the pharmacy. Good theory- this is how it should be. Too bad that in practical actual usage it's actually not always true. I've contacted my doctor for further info, as per the suggestion listed- and he agreed with me.
> http://www.fda.gov/cder/ogd/
>
> Frequently Asked Questions about Generic Drugs
>
> 1. What are generic drugs?
> 2. Are generic drugs as safe as brand-name drugs?
> 3. Are generic drugs as strong as brand-name drugs?
> 4. Do generic drugs take longer to work in the body?
> 5. Why are generic drugs less expensive?
> 6. Are brand-name drugs made in more modern facilities than generic drugs?
> 7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
> 8. Does every brand-name drug have a generic counterpart?
> 9. What is the best source of information about generic drugs?
>
> 1. What are generic drugs?
>
> A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
>
> back to top
>
> 2. Are generic drugs as safe as brand-name drugs?
>
> Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
>
> back to top
>
> 3. Are generic drugs as strong as brand-name drugs?
>
> Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.
>
> back to top
>
> 4. Do generic drugs take longer to work in the body?
>
> No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.
>
> back to top
>
> 5. Why are generic drugs less expensive?
>
> Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.
>
> back to top
>
> 6. Are brand-name drugs made in more modern facilities than generic drugs?
>
> No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
>
> back to top
>
> 7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
>
> In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
>
> back to top
>
> 8. Does every brand-name drug have a generic counterpart?
>
> No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.
>
> back to top
>
> 9. What is the best source of information about generic drugs?
>
> Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.
>
> Consumer Education: Generic Drugs
Posted by Squiggles on February 28, 2007, at 19:00:18
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 18:57:11
> Oh yes- I've seen this notice at the pharmacy. Good theory- this is how it should be. Too bad that in practical actual usage it's actually not always true. I've contacted my doctor for further info, as per the suggestion listed- and he agreed with me.
But how many cases have you seen? You say
it's not "always" true. How often has it been
false? And do you know why? I think that you may assume that the drug is different because it is generic, when so many other influences have been overlooked.Squiggles
Posted by laima on February 28, 2007, at 19:52:22
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 19:00:18
"Other influences"- like my being delusional? Or you fancy I am someone who insists on brand-name designer products, or thinks that expensive=better? Hardly! All I want is for my medication to work properly.What I can guarentee you is that Barr generic "adderall" and the Shire brand Adderall felt like entirely different drugs: radically different effects. They might have had a few molecules in common, but they did not do the same thing- AT ALL. I can also guarentee you that I've seen other patient testimonials reporting the very same results that I got, and I read them after the fact-ie, was not suggestably influenced by them. I can also guarentee you that my doctor agreed with zero hesitation or reservation that generics are not necessarily the same as the original versions. Some are more notoriously different and are more often and vigorously complained about by patients than others. You might have noticed that prescription pads even have a section where the doctor can choose to indicate: "Do Not Substitute". I can guarentee you that until recently, I could go to Walgreens and choose Shire or Barr, and now I can choose have Barr or nothing. I thought generics were intended to offer consumers choices? I got less choice. And, in the US, I am pretty darn certain that generic manufacturers are just as interested in turning a profit as the developers and pharmacies are. They are not non-profit entities run by selfless philanthropists, smiled upon and encouraged by a kind and attentive government which has nothing but public welfare in mind. And I've seen plenty of reports of the fda being pretty overwhelmed and spread thin these days. Checking to be sure generics BEHAVE in the same way as originals doesn't sound to be a top priority. Nor does it really sound to be required, if you dig around deep enough into the rules of standards they need to meet.
Maybe it's a little like cooking: you can give a bunch of people the exact same recipee and groceries, but I know the results do not always end up tasting the same-despite the molecules presumabley being the same. It's usually due to their talents and methods. But with drugs- it's more serious- if the results do not end up with the same therapeutic benefits.
Since this seems to be turning into another case of touting the 'ole "generics are exactly interchangeable with brand name originals- any differences are imaginary", line, I give up. Anything I say seems likely only be used to demonstrate how delusional I am about my own experience by those who feel generics are a sincere and angelic public service, and so really, what's the point?
Yes, actually in the past there have been reports by several people here on babble asserting strongly that generic versions of clonazapam are not the same as brand Klonopin- but I don't have personal experience of comparing them myself. All I've ever personally noticed is that the current generic clonazapam Walgreens offers is weaker and much shorter acting than the one they used to offer. And that it has tended to fuzz me up rather than relieve any anxiety or worry.
If all your particular generics are working out great for you- fantastic! Count your blessings.
> But how many cases have you seen? You say
> it's not "always" true. How often has it been
> false? And do you know why? I think that you may assume that the drug is different because it is generic, when so many other influences have been overlooked.
>
> Squiggles
>
Posted by Squiggles on February 28, 2007, at 20:01:15
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 19:52:22
>
> "Other influences"- like my being delusional?
I'm waiting for the deputees to spank you. This is the second time offense has been given; another post to me was "do you like your sex kinky or straight". Nothing was done. Either these things are missed, or I am excluded from the rules here for some reason.Squiggles
Posted by laima on February 28, 2007, at 21:14:00
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on February 28, 2007, at 20:01:15
It may not be an official rule, but I actually think it's a spankable offense to insist someone's condition, diagnosis, or experience is imaginary. Very hurtful, too. If this isn't what you are inferring, what are you trying to tell me?That other post you mention wasn't from me- I have no interest in your sex life and am sorry and diossapointed to hear someone wrote that. No, no one batted an eye when in the past someone suggested I must be a drug addict, abuser, either. The reasoning was that's the only way to develop benzo tolerance.
> >
> > "Other influences"- like my being delusional?
>
>
> I'm waiting for the deputees to spank you. This is the second time offense has been given; another post to me was "do you like your sex kinky or straight". Nothing was done. Either these things are missed, or I am excluded from the rules here for some reason.
>
> Squiggles
Posted by Squiggles on March 1, 2007, at 7:36:26
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on February 28, 2007, at 21:14:00
>
> It may not be an official rule, but I actually think it's a spankable offense to insist someone's condition, diagnosis, or experience is imaginary. Very hurtful, too. If this isn't what you are inferring, what are you trying to tell me?
>
>Thank you for your courteous reply. OK- I am suggesting that it would be very difficult to detect lack of bioavailability or bioequivalence in generics once they are on the market. If I understand bioavailability correctly, it may be easier to detect that. So, my point is that you would have to do a really massive statistical test on *suspected* bad generics. You may as well try it on brand-name ones. The FDA, and Health Canada sometimes *do* find error in these drugs and report it, but I don't know that there are more such reports for brand-name drugs than generics-- I don't think so.
Squiggles
Posted by laima on March 1, 2007, at 9:12:27
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on March 1, 2007, at 7:36:26
Well, whatever the reality of the laws and inspections turn out to be, the fact is that for this particular case, this particular generic does not behave like the original it is supposed to be interchangeable with, and I can't exagerate how frustrating and upsetting it has been to have umpteem pharmacists roll their eyes and insist I'm wrong. And part two of the upset- I go through hours of traipsing around the city to find what has worked for me- only to discover when I got home that the particular generic company I didn't do well with took over the brand version. Will that mean some minor tweaks will happen that add up to it no longer working out for me? I guess there is no way to know at this time, logically. I know other generic versions exist, but in practical terms, I might have a hard time getting my hands on them since Barr has an apparent monopoly with the pharmacy my insurance requires me to use. Besides- now I can't help but wonder if they are all different too! So it's been frustrating.
In another thread, someone offered an amazing insight. He actually prefers Barr, and explained he's got a theory or suspicion that Shire's version either contains more dexedrine or releases it differently- and he doesn't like dexedrine. I've done well with dexedrine in the past, and liked it a lot. He feels Barr contains either more l-amphetamine-or releases it differently- and he feels l-amphetamine agrees with him better. Perhaps that's part of what I reacted to, should there be anything to this theory. So I found it to be very interesting. I'll see how the month goes, if I still think I have a problem by the end of the month, I may ask my doctor about dexedrine. In fact, the dexedrine I trialed in the past was a generic version-not sure the brand- and it agreed with me very nicely. Just was too much stimulation in combination with welbutrin, but that's another story I won't get into here. I still believe for a number of reasons that the fda is paying more attention to brand name new drugs than to generics, which have been turning out their products for years, but I can't offer you any proof, and to start digging for irrefutable proof will ultimately only end up taking loads of time and upsetting both of us-and I see no value in that. Wouldn't be useful in any practical way anyway.
Yes- I am all in favor of generics that help patients! I've used many generics myself, and have never had an objection about one ever before. This particular one didn't help me one bit, and I've been very dismayed to find it doesn't behave like the original version. The other poster loves Barr version, so perhaps "bad generics" isn't even a good term to use. In my ideal world, the drug descriptions would be clear and open about that this version is like this, that one is a little more like that.
Well, thank you for your reply, too. I don't wish to be argumentative- and I always enjoy reading your thoughtful posts. I've had a difficult time not feeling defensive just because I've been (generally speaking- not specific to yourself) encountering an awful lot of skepticism over my experience. Ie- "no-no-you're not feeling that, see, the chart here says it's impossible for you to feel that", etc. Enough to drive the most sane and stable person absolutly nuts.
I hope that makes sense.So I'll go try to think about other things now.
> Thank you for your courteous reply. OK- I am suggesting that it would be very difficult to detect lack of bioavailability or bioequivalence in generics once they are on the market. If I understand bioavailability correctly, it may be easier to detect that. So, my point is that you would have to do a really massive statistical test on *suspected* bad generics. You may as well try it on brand-name ones. The FDA, and Health Canada sometimes *do* find error in these drugs and report it, but I don't know that there are more such reports for brand-name drugs than generics-- I don't think so.
>
> Squiggles
Posted by Squiggles on March 1, 2007, at 9:26:23
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by laima on March 1, 2007, at 9:12:27
> Well, whatever the reality of the laws and inspections turn out to be, the fact is that for this particular case, this particular generic does not behave like the original it is supposed to be interchangeable with, and I can't exagerate how frustrating and upsetting it has been to have umpteem pharmacists roll their eyes and insist I'm wrong.
I can understand your frustration, and any pharmacist with an open mind should be able to imagine that both generics and brand-name drugs can go off for some reason (the lab, the country of import, the storage conditions, the ratio of filler and active ingredient, etc.).
And part two of the upset- I go through hours of traipsing around the city to find what has worked for me- only to discover when I got home that the particular generic company I didn't do well with took over the brand version. Will that mean some minor tweaks will happen that add up to it no longer working out for me?Possibly-- if generix x is weak then adding to it will help, if brand-x is too strong, then taking away-- but here we are entering a chemical wonderland. I think you need a chemist at this point.
I guess there is no way to know at this time, logically. I know other generic versions exist, but in practical terms, I might have a hard time getting my hands on them since Barr has an apparent monopoly with the pharmacy my insurance requires me to use. Besides- now I can't help but wonder if they are all different too! So it's been frustrating.
It's so complicated, that I would ask my dr. if there is an equivalent drug to Adderall that you can take. Also, take a look at the FDA or CDER to see if there any reports on your drug being off.
>
> In another thread, someone offered an amazing insight. He actually prefers Barr, and explained he's got a theory or suspicion that Shire's version either contains more dexedrine or releases it differently- and he doesn't like dexedrine. I've done well with dexedrine in the past, and liked it a lot. He feels Barr contains either more l-amphetamine-or releases it differently- and he feels l-amphetamine agrees with him better. Perhaps that's part of what I reacted to, should there be anything to this theory. So I found it to be very interesting. I'll see how the month goes, if I still think I have a problem by the end of the month, I may ask my doctor about dexedrine. In fact, the dexedrine I trialed in the past was a generic version-not sure the brand- and it agreed with me very nicely.The variability proves that not all generics are likely to be weaker or brand-name ones to be stronger.
Just was too much stimulation in combination with welbutrin, but that's another story I won't get into here.
Wellbutrin itself is a stimulating AD-- why do they use this drug without a sedatory one, i can't understand.
I still believe for a number of reasons that the fda is paying more attention to brand name new drugs than to generics, which have been turning out their products for years, but I can't offer you any proof, and to start digging for irrefutable proof will ultimately only end up taking loads of time and upsetting both of us-and I see no value in that. Wouldn't be useful in any practical way anyway.
I agree. Experience is probably the best thing to go with.
>
> Yes- I am all in favor of generics that help patients! I've used many generics myself, and have never had an objection about one ever before. This particular one didn't help me one bit, and I've been very dismayed to find it doesn't behave like the original version. The other poster loves Barr version, so perhaps "bad generics" isn't even a good term to use. In my ideal world, the drug descriptions would be clear and open about that this version is like this, that one is a little more like that.Well, as the post i sent says, many of the drugs people get ARE generics and they are not even aware of it-- not recognizing the brand and non-brand names on the pill or cap.
>
> Well, thank you for your reply, too. I don't wish to be argumentative- and I always enjoy reading your thoughtful posts. I've had a difficult time not feeling defensive just because I've been (generally speaking- not specific to yourself) encountering an awful lot of skepticism over my experience. Ie- "no-no-you're not feeling that, see, the chart here says it's impossible for you to feel that", etc. Enough to drive the most sane and stable person absolutly nuts.
> I hope that makes sense.
>I understand. I can't say that I have not experienced a weak generic. But many of the drugs sold now are generic. Some old ones with expired patent, are nothing BUT generics.
With the trouble you describe, I would ask my dr. if there is an equivalent *drug* to Adderall. It seems that we have too many drugs on the market and this has caused a lot of confusion. That is a profit-motivated market in the pharmaceutical companies-- does not profit anyone but them. I suppose this may be an exceptional case.
Squiggles
Posted by Larry Hoover on March 1, 2007, at 10:04:01
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on March 1, 2007, at 9:26:23
> > Well, whatever the reality of the laws and inspections turn out to be, the fact is that for this particular case, this particular generic does not behave like the original it is supposed to be interchangeable with, and I can't exagerate how frustrating and upsetting it has been to have umpteem pharmacists roll their eyes and insist I'm wrong.
>
>
> I can understand your frustration, and any pharmacist with an open mind should be able to imagine that both generics and brand-name drugs can go off for some reason (the lab, the country of import, the storage conditions, the ratio of filler and active ingredient, etc.).This is the crux of the issue, IMHO. What, do the pharmacists think we'd make up a story of lesser efficacy/greater side effects? I don't care what the paperwork says, the differences would only be mentioned if there were any. End of story. The patient is not being taken seriously, or given any credibility. Why would a patient who is saving money complain?
Lar
Posted by laima on March 1, 2007, at 10:50:20
In reply to Re: Drug manufacturing and quality control, posted by Squiggles on March 1, 2007, at 9:26:23
Thanks Squiggles. Well, I've tried doing tons of research to answer my questions, but this all just seems to be so recent and I can't find any relevant information. Meanwhile, I've wasted loads of time and have only gotten more worked up over the matter. The pharmacists are content to toat like broken records their company policy and well-known fda notice about how the generics are interchangeable with brand. Per rational common sense I think I'm going to have to just get on with my other activities, and see how the month goes. I can also ask at my next appointment if dr. has any news. If things don't end up going well, later, when I'm more objective, I guess it will be time to look at alternatives. Obsessing only blows problems up out of proportion, I know that really.
Posted by laima on March 1, 2007, at 10:58:03
In reply to Re: Drug manufacturing and quality control » Squiggles, posted by Larry Hoover on March 1, 2007, at 10:04:01
Thank you, Larry, for posting this. I do feel much better feeling someone actually can believe me about my experience, despite of what the official paperwork says. It certainly is an awful and indescribably maddening feeling to be treated dismissably, like "mental patient delusionally insists medication doesn't work right, when we professional experts and the government all know better". Well, if there's something that could render an antidepressent ineffective- how about that for a starter?But like I said, I think it will be in my best interest for now to occupy muself with other concerns, because I'm dwelling, and that's never helpful.
Thank you, again.
> This is the crux of the issue, IMHO. What, do the pharmacists think we'd make up a story of lesser efficacy/greater side effects? I don't care what the paperwork says, the differences would only be mentioned if there were any. End of story. The patient is not being taken seriously, or given any credibility. Why would a patient who is saving money complain?
>
> Lar
Posted by Squiggles on March 2, 2007, at 12:42:54
In reply to Re: Looking for the Middle Ground Here, posted by med_empowered on February 23, 2007, at 23:02:35
Just got this from e-drug Digest, newly formed:
http://www.usp.org/worldwide/dqi/
Enjoy.
Squiggles
Posted by KayeBaby on October 9, 2007, at 19:20:06
In reply to Re: Drug manufacturing and quality control » Larry Hoover, posted by laima on March 1, 2007, at 10:58:03
Sorry for digging up this old post but 2 weeks ago I was talked into trying the generic adderall and it is the pits. I have been a mess since day one on it. The month before I had brand and all was well. Since I started on the generic I have been wracking my brain trying to figure out what has went wrong with me. I have changed my supplements and everything I could think of till it dawned on me that I got generic and that is when things started going south.
Anxiety, irritability awful. Insomnia the first week, now depressed and ill feeling. I noticed that I feel ok till that crap kicks in. I am calling my dr to see if I can return the unused generics and get another script for brand.
Oh, I had a couple of brand from last month and tested them out and felt a lot better. This is certainly not my imagination.
Those generics suck!
I'm mad I had two awful weeks because of them when I have been so well.Feels like ephedrine or some crud like that!
Kaye
Posted by Squiggles on October 9, 2007, at 20:28:01
In reply to Re: Drug manufacturing and quality control » laima, posted by KayeBaby on October 9, 2007, at 19:20:06
> Sorry for digging up this old post but 2 weeks ago I was talked into trying the generic adderall and it is the pits. I have been a mess since day one on it. The month before I had brand and all was well. Since I started on the generic I have been wracking my brain trying to figure out what has went wrong with me. I have changed my supplements and everything I could think of till it dawned on me that I got generic and that is when things started going south.
>Every generic drug I have tried, has been weaker
than the non-generic. Infact, I suspect that the
lithium catastrophe may have been a result of
a generic type - as i asked for a generic, and at that time Health Canada had placed a warning about generic lithium being weak. In the case of a friend of mine, i believe that her switch to a generic AD, caused her to misinterpret her symptoms for the underlying illness, when infact it was a sub-therapeutic dose from a generic.As I may now speak freely, having attained some greater degree of freedom, yes, i agree generics are not what they claim to be, in my experience-- ditto for Xanax and for Rivotril. I dread the coming of the thyroxine preparations in generic form.
Squiggles
> Anxiety, irritability awful. Insomnia the first week, now depressed and ill feeling. I noticed that I feel ok till that crap kicks in. I am calling my dr to see if I can return the unused generics and get another script for brand.
>
> Oh, I had a couple of brand from last month and tested them out and felt a lot better. This is certainly not my imagination.
>
> Those generics suck!
> I'm mad I had two awful weeks because of them when I have been so well.
>
> Feels like ephedrine or some crud like that!
>
> Kaye
Posted by KayeBaby on October 10, 2007, at 16:28:26
In reply to Re: Drug manufacturing and quality control » KayeBaby, posted by Squiggles on October 9, 2007, at 20:28:01
I had a free trial for Vyvanse that my Dr. had given me to try so i filled that yesterday and started it today. The difference is amazing.
I don't have that down, depressed feeling today. My mood has been an "I hate everything" one for the last two weeks and no focus. I have had focus and energy today and am feeling more upbeat in my mood. Could actually consider seeing people whereas on the generic adderall I want to hide.
The people responsible for that product should be whipped.
Kaye
Posted by Squiggles on October 10, 2007, at 16:58:28
In reply to Re: Drug manufacturing and quality control, posted by KayeBaby on October 10, 2007, at 16:28:26
> I had a free trial for Vyvanse that my Dr. had given me to try so i filled that yesterday and started it today. The difference is amazing.
>
> I don't have that down, depressed feeling today. My mood has been an "I hate everything" one for the last two weeks and no focus. I have had focus and energy today and am feeling more upbeat in my mood. Could actually consider seeing people whereas on the generic adderall I want to hide.
>
> The people responsible for that product should be whipped.
>
> KayeI take that Vyvanse is the brand-name bioequivalent for adderall?
I just found out today that the American Medical Association makes a significant distinction between the methods used to assess "bioequivalence" and therapeutic efficacy. The two are not the same at all. They use different tests-- bioequivalence being an empirical, statistical comparison, and therapeutic being biologically targeted for physiological variation and response. The difference is particularly important for drugs with a narrow therapeutic index, as studies have shown that identical amounts and contents yield clinically significant differences. The FDA has ignored this difference and has not intervened in dangerous adverse effects.
Squiggles
for
Posted by KayeBaby on October 11, 2007, at 11:41:24
In reply to Re: Drug manufacturing and quality control » KayeBaby, posted by Squiggles on October 10, 2007, at 16:58:28
Vyvanse is actually dexaphetimine designed to release and be effective for 10 hrs.
It is working well for me so far.when it comes to psyche meds the difference in some generic meds is obvious. Makes you wonder about the one we cannot discern by "feel" like antibiotics.
Kaye
Posted by Squiggles on October 11, 2007, at 16:40:55
In reply to Re: Drug manufacturing and quality control, posted by KayeBaby on October 11, 2007, at 11:41:24
> Vyvanse is actually dexaphetimine designed to release and be effective for 10 hrs.
> It is working well for me so far.
>
> when it comes to psyche meds the difference in some generic meds is obvious. Makes you wonder about the one we cannot discern by "feel" like antibiotics.
>
>
> KayeThis one sounds like a stimulant by the spelling.
You have a good point about psychoactive drugs making conscious feedback a possibility. With drugs that act on at least non-immediately sensed effects, the outcome may be assessed too late, e.g. HIV drugs.Squiggles
This is the end of the thread.
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