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(LA Times)   In a surprising moment of clarity, the FDA admits that when it comes to generic drugs, sometimes you get what you pay for   (latimes.com) divider line 91
    More: PSA, FDA, drug safety, Teva Pharmaceuticals  
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8214 clicks; posted to Main » on 06 Oct 2012 at 2:38 PM (2 years ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



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2012-10-06 05:39:52 PM  
Generic meds generally suck. India is now offshoring production to China and I have already experienced how well that works. The only good thing is brand name drug makers are trying to recapture market share by selling brand name in different packaging for slightly more than generic cost. The FDA is trying to cling to the perfect world "100% bioequivalency" pushed by big pharma and generic manufacturers while in the real world you get what you pay for. Canada has a good state quality check system where generic meds purchased for their national health program have to be at least 90% of their stated drug content.
 
2012-10-06 05:40:49 PM  

OhLuverly: You come to the counter. I am on the phone with a drunk dude who wants the phone number to the grocery store next door. After I instruct him on the virtues of 411, you tell me your doctor was to phone in your prescription to me. Your doctor hasn't, and you're unwilling to wait until he does. Being in a generous mood, I call your doctors office and am put on hold for 5 minutes, then informed that your prescription was phoned in to my competitor on the other side of town. Phoning the competitor, I am immediately put on hold for 5 minutes before speaking to a clerk, who puts me back on hold to wait for the pharmacist. Your prescription is then transferred to me, and now I have to get the 2 phone calls that have been put on hold while this was being done. Now I return to the counter to ask if we've ever filled prescriptions for you before. For some reason, you think that "for you" means "for your cousin" and you answer my question with a "yes", whereupon I go the computer and see you are not on file.

The phone rings.

You have left to do something very important, such as browse through the monster truck magazines, and do not hear the three PA announcements requesting that you return to the pharmacy. You return eventually, expecting to pick up the finished prescription.....

The phone rings.

......only to find out that I need to ask your address, phone number, date of birth, if you have any allergies and insurance coverage. You tell me you're allergic to codeine. Since the prescription is for Vicodin I ask you what exactly codeine did to you when you took it. You say it made your stomach hurt and I roll my eyes and write down "no known allergies" You tell me......

The phone rings.

.....you have insurance and spend the next 5 minutes looking for your card. You give up and expect me to be able to file your claim anyway. I call my competitor and am immediately put on hold. Upon reaching a human, I ask them what insurance they have on file for you. I get the information ...


Do you work at that pharmacy I go to? Because that's exactly what I see the poor guy dealing with, even on the graveyard shift.
 
2012-10-06 05:42:39 PM  
Every so often, very well paid researchers, chemists or engineers come up with something that works.

And that thing is then owned by the company they work for who mark it up substantially so they can make billions and buy new Maybachs.

Then, some other company who would at least like to have new Mercedes make a sh*tty knock off of it and flog it to poor people who can't afford the one that works.

If you are poor, you have no reasonable expectation of getting what you are purported to be buying because nobody gets stinking rich off of it, and that's s the only reason corporations do anything at all. And that's how sh*t works around here, Charlie Brown.
 
2012-10-06 05:55:02 PM  
Yeah, this has nothing to do with it being a generic drug and everything to do with shiatty business practices and poor quality control.
 
2012-10-06 05:58:35 PM  

xmasbaby: but the phrase I want you to look for is "The FDA requires the bioequivalence of the generic product to be at least 80% of that of the innovator product."

In reality, the cheapest and easiest way to make a generic drug is to start with 20% less of the active ingredient.


Wait wait wait. That cannot possibly mean that the FDA is okay with someone labeling their generic version of OxyContin™ as "40mg oxycodone" when it only contains 32mg. What it does mean, according to the Wiki you're citing, is that they can use cheaper binding agents, delivery methods, salts, etc. That may mean that as little as 80% of the effect is felt by the body (or as much as 125%) but it does NOT mean they're just skimping on the main ingredient.

Sure, generics are cheaper for a reason. Sometimes a stupid reason (the same company makes it but slaps a different price on it), sometimes a good reason (the generic company doesn't have the massive overhead budget of a research company trying to break new ground), and sometimes a very bad reason (overall poor quality control at the factory, etc.). But not for that reason, unless they're just flat-out breaking the law.
 
2012-10-06 05:59:22 PM  

Morgellons: The hell are you on about?

FIRST of all, "Brand name" percocet is contracted out to Mallinckrodt, who also makes the generic. SAME GODDAMNED PILL!

SECOND, the "80%" thing means that each BATCH of drug contains +/- 20% of the active ingredient as advertised, something name brand drugs must also adhere to.

THIRD, I pray to FSM I never get your stupid ass as an anesthaesiologist.


I hope you never get me as an anesthesiologist either. I hope you never get sick, need surgery, or need prescription medication for that matter. I hope you live a full, happy and healthy life.

I don't have any idea about what goes on in the Mallinckrodt factories, and hope their generic percocet is exactly the same as their branded Percocet, because that would be awesome and there would never be any reason for a single branded Percocet to ever be sold again. I do know that just because a company manufactures two similar products doesn't mean they are the same. If you were an MBA at Mallinckrodt, wouldn't you be looking for ways to market the brand name product as being worth the upcharge, while looking for ways to reduce costs on your cheaper product?

Guess what phrase you never, ever hear? "Oh please don't give me the generic equivelent of (Valium, Percocet, etc), that generic stuff is just too powerful."

There is no question that generic drugs are almost always cheaper, but I think it is a mistake to believe that the trade name drug and generic are identical, especially when legally, they can put in 20% less active ingredient and charge 10% less.
 
2012-10-06 06:01:26 PM  

OhLuverly: You come to the counter. I am on the phone with a drunk dude who wants the phone number to the grocery store next door. After I instruct him on the virtues of 411, you tell me your doctor was to phone in your prescription to me. Your doctor hasn't, and you're unwilling to wait until he does. Being in a generous mood, I call your doctors office and am put on hold for 5 minutes, then informed that your prescription was phoned in to my competitor on the other side of town. Phoning the competitor, I am immediately put on hold for 5 minutes before speaking to a clerk, who puts me back on hold to wait for the pharmacist. Your prescription is then transferred to me, and now I have to get the 2 phone calls that have been put on hold while this was being done. Now I return to the counter to ask if we've ever filled prescriptions for you before. For some reason, you think that "for you" means "for your cousin" and you answer my question with a "yes", whereupon I go the computer and see you are not on file.

The phone rings.

You have left to do something very important, such as browse through the monster truck magazines, and do not hear the three PA announcements requesting that you return to the pharmacy. You return eventually, expecting to pick up the finished prescription.....

The phone rings.

......only to find out that I need to ask your address, phone number, date of birth, if you have any allergies and insurance coverage. You tell me you're allergic to codeine. Since the prescription is for Vicodin I ask you what exactly codeine did to you when you took it. You say it made your stomach hurt and I roll my eyes and write down "no known allergies" You tell me......

The phone rings.

.....you have insurance and spend the next 5 minutes looking for your card. You give up and expect me to be able to file your claim anyway. I call my competitor and am immediately put on hold. Upon reaching a human, I ask them what insurance they have on file for you. I get the information ...


It sounds like your pharmacy is built wrong. You should have one guy shoving pills into bottles, one guy telling people to go fark themselves, and one guy answering the phone.
 
2012-10-06 06:06:54 PM  

office_despot: One of my colleagues is taking Synthroid, and refuses the generic because the same kinds of "rumors" from users are out there concerning its effectiveness. Our insurance won't pay for name-brand Synthroid, so he pays out of pocket for it. I wonder whether the FDA will look into that, too.

Also, regarding birth control, I don't even remember which option this was or whether it was a Teva drug, it was so long ago, but at one point the gynecologist gave me a long explanation of why the generic version of one drug was not actually the same as the more expensive name brand. I figure the doctor ought to know.


My doc told me the FDA doesn't police for matching chirality. All I know is I tried this one generic twice and both times broke out in this horrible cystic acne like I never imagined was possible. Cleared up immediately on switching back to the brand name. On another pill the generic correlated with inexplicable depression. I finally stopped experimenting with generic birth control after that.
 
2012-10-06 06:10:07 PM  
In a surprising moment of clarity, the FDA admits that when it comes to generic drugs, sometimes you get what you pay for

Actually, Subby, the content of the article makes it clear that the problem is people not getting what they paid for. When you pay for a generic you are supposed to get the drug. When you pay for a name-brand you get the same drug + a different name and fancy package.
 
2012-10-06 06:11:20 PM  

BigLuca: If I hear "I can only take brand-name Percocet, I'm allergic to all the generics" one more time, I swear to god i will kick the speaker right in the nuts, or get my foot stuck trying.


Lol the only reason they want brand name is because they're easier to sell.
 
2012-10-06 06:13:07 PM  

Oznog: Well I noticed this:

Modafinil had a brand name Provigil. Then came the all-brand-new Nuvigil (armodafinil) from the same company, which is also modafinil. Sort of.

Modafinil has both left- and right-handed enantiomer versions of its molecules. Modafinil/Provigil is racemic- an equal mix of both. Of those, Nuvigil (armodafinil) is only the (−)-(R)-enantiomer of it.

So modafinil has always been 50% armodafinil... and 50% the left-handed version, which has no specific name other than modafinil. The armodafinil enantiomer is supposed to be substantially more active.

Just noting, the importance of the ratio of left- and right-handed enantiomers MIGHT be important, yet disregarded by generic mfgs, and that could account for "differences".

Of course, the original patent holder is not inclined to "help" with such issues. They hold the secrets pretty tightly and would be delighted if the generic version couldn't deliver the same results.


The only reason generic mfgs don't make the right-handed-only version is because it is still under patent. In 20 years (or a little more or less given development and delay lawsuits) there will be tons of generic manufactures making the dextro-only version. In fact that is the pattern of drug manufacturing. The original company comes out with a patented drug, they sell it as brand with total patent protection for 20 years. Once their patent protection period is up other generic manufactures can apply to make the drug. So the original drug manufacture "tweaks" the formula a bit (usually making a left or right only version, or a new salt of the original drug) and applies for a patent on the "new" drug. Then they get a new 20 year period of exclusivity on this new drug.

Simplified process and there is a huge amount of variation, but that is the basic pattern. And I don't mean to imply that righ/left versions of drugs are not big changes, chemically they are small, but medically there can be huge differences. OTC meth for instance Link
 
2012-10-06 06:17:08 PM  

semiotix: Wait wait wait. That cannot possibly mean that the FDA is okay with someone labeling their generic version of OxyContin™ as "40mg oxycodone" when it only contains 32mg. What it does mean, according to the Wiki you're citing, is that they can use cheaper binding agents, delivery methods, salts, etc. That may mean that as little as 80% of the effect is felt by the body (or as much as 125%) but it does NOT mean they're just skimping on the main ingredient.

Sure, generics are cheaper for a reason. Sometimes a stupid reason (the same company makes it but slaps a different price on it), sometimes a good reason (the generic company doesn't have the massive overhead budget of a research company trying to break new ground), and sometimes a very bad reason (overall poor quality control at the factory, etc.). But not for that reason, unless they're just flat-out breaking the law.


Actually it does, and as far as I know, there is no law that says a generic equivalent has to contain the same amount of active ingredient, either in mg or molecules. If I'm mistaken, I will be very happy to discover it.

But if have you're manufacturing a drug, and want to sell a generic equivalent and want to make as much money has possible selling a generic equivalent to compete with your own successful drug, how would you do it?

Would you just sell the same drug with different numbers and letters stamped on it? Would you spend the time and money to research a new formulation?

Or would you simply take the formula you've already spent hundreds of millions of dollars developing and testing and make sure that your generic equivalent has 80% of the bioavailability by putting in a 80% of the original formulation? (assume a conscienceless team of drug company executives) That would be a perfectly legal way to achieve 80% bioavailablity while maximizing your profits and keeping a market for your tradename drug.

I'm not saying that all generic drugs are crap, but I am saying that if you believe you are buying "the exact same thing" when the drug company only has to deliver 80% of the bioavailability of the original, you might want to retain some healthy skepticism.
 
2012-10-06 06:29:14 PM  

BigLuca: OhLuverly: So glad I'm in hospital pharmacy instead of retail pharmacy now. Retail pharmacies are going to be dealing with weeks of patients insisting on brand named everything (99% which isn't stocked in pharmacies anymore)

Tech, PharmD, or student?


Oh good lord .... I am really glad my wife has retired from that biz. You're totally right, both of you.

/Wife is RPh.
 
2012-10-06 06:50:31 PM  

xmasbaby: Actually it does, and as far as I know, there is no law that says a generic equivalent has to contain the same amount of active ingredient, either in mg or molecules. If I'm mistaken, I will be very happy to discover it.


You're saying that if you label something "40 mg oxycodone" it doesn't have to contain 40 mg of oxycodone?! That would make drugs the only consumer good in existence where you could deliberately mislabel. Try doing that with a bottle of water and the FTC will fine you out of existence.

Again, it's pretty clear from the link you gave that they're talking about bioavailability. The real smart kiddies snort their Ritalin™ instead of swallowing it, because snorting gets more of it into the bloodstream faster. Likewise, a cool space-age pill with special buffers and time-release coatings might get 20% more of the drug into your system than the cheapo generic binders that let your stomach acids destroy some of the payload.

Maybe there's no law that says that generic drugs have to be sold in the same dosages as their name-brand equivalent. So maybe generic oxycodone could be sold in 30 mg tablets instead of the usual 40. I don't know. But I'm still not seeing anything that lets them just outright lie about how much active ingredient is in there.
 
2012-10-06 06:53:46 PM  

xmasbaby:
Or would you simply take the formula you've already spent hundreds of millions of dollars developing and testing and make sure that your generic equivalent has 80% of the bioavailability by putting in a 80% of the original formulation? (assume a conscienceless team of drug company executives) That would be a perfectly legal way to achieve 80% bioavailablity while maximizing your profits and keeping a market for your tradename drug.

I'm not saying that all generic drugs are crap, but I am saying that if you b ...


I have no idea where you are this 80% from. Did you post a link? I can almost guarantee you that is not true. The only thing I can possible think of is that you are confusion a confidence interval which is commonly held at 80% for many equivalency studies. But that does NOT mean that they just have to be within 80% of active ingredient. Furthermore, the generic manufactures are held to the same standard of accuracy as the brand manufactures. As many people in the thread have stated the only significant difference between brand and generic is (maybe) rate of absorption. And even that is usually negligible.
 
2012-10-06 07:01:55 PM  
The biggest problem with generics is that they are not required to list ADRs which are discovered after they've hit te market. The name brands are required to update their Side Effects May Include Death and Disfigurement insert after a certain number of people are killed and maimed by the product, but the generics can just list Don't Eat Dairy Or You Might Puke if that's all that was conclusively known to be a side effect when they were able to license the formula.
 
2012-10-06 07:16:06 PM  
I've spoken to several doctors about my concern over generics. I get it that the active ingredient is (supposedly) the same as the name-brand, but what about all the other stuff that goes into those pills? Has anyone ever done studies to check how those different ingredients can interact with the actual medicine in the pill? Two of my doctors did agree admit that they shared the same concern and always recommended that if their patient could afford it, they should stick with the name-brands.
 
2012-10-06 07:17:49 PM  
xmasbaby
Ah, I found it. Yes, wikipedia stated that the manufacture had to be within 80%-125% and then they cited this article Link As happens from time to time, wikipedia is wrong. This is the relevant section from the FDA article:
The confidence interval for both pharmacokinetic parameters, AUC and Cmax, must be entirely within the 80% to 125% boundaries cited above.

They are talking about confidence interval, NOT bioequivalence in reference to the percentages listed. Totally different.  If you are interested in how they came up with this confidence interval, a good explanation is here: Link "ctrl-f for 80%"

WOT from the presentation linked:
Using the bioequivalence criteria that I mentioned, there should be a few questions that come to everyone's mind when you first look at this. The first is an understanding that the mean isn't allowed to be as low as 80% or as high as 125%, but how do we come up with the 80% to 125%?
It seems a bit lopsided in that when you first look at it, we allow the 90% confidence interval of the test versus reference to be 25% above, in other words, the test is greater than the reference but on the other side we don't allow the 90% confidence interval to be less than 20% below (test is less than reference). What is the logic in that? It is based on actual statistical calculations that were done to this equivalence comparison. Most of the statistics that we've learned in courses and perhaps apply even to clinical studies are really attempting to show the difference between two or more things.
When one does a classical statistical test like a T test, you really come up with a conclusion that the two things are different or conversely, if you're unable to show that they're different, that you're unable to show that they're different. When you're unable to show that they're different, it doesn't mean that they're the same. It isn't a proof of sameness. It's simply that you failed to show they're different.
What we want, however, for bioequivalence is a statistically valid conclusion that the two things are the same within an acceptable range. The standard statistical approaches that we all know are not appropriate to get that conclusion. So some clever statisticians at the FDA came up with an adaption of the usual statistics to allow us to draw a conclusion of equivalence, not just an absence of difference.
The way they did this was called the one-sided test procedure. The approach simply is that two one-sided tests, very similar to T tests, are performed on this data. The first of the tests says that the test or T is not significantly less than the reference. The second test, that the reference is not significantly less than the test. So clinically, if I were to have a patient who goes into the pharmacy and is already on the brand name and the generic is substituted, I don't want the generic to be significantly less than what the patient is already on. Conversely, if the patient is on the generic and goes into the pharmacy and the reference is substituted for that product, I don't want that reference that the patient gets to be any less than what the patient is already on.
Those are the two tests that are done. Based on a lot of clinical experience and clinical input, the significant difference for statistical purposes was stated at 20%. That does not mean that the mean is allowed to be 20%. That's just the clinically significant difference that one sets for statistics. That's done statistically at an alpha level of 0.05 significance level for each of these tests. That's important, as I'll explain.
To express this mathematically, the T/R ratio of the first test, the maximum being 80/100, would be 80%. The second one, the R/T, also would be 80%. However, for a matter of convention, we express both of those in a comparable manner as T/R. We always speak of the test over reference. So R/T has to be converted to T/R by inverting it and it ends up having 100/80 or 125%.
It's merely that you'd have to take the reciprocal of the second one to end up with this somewhat odd-looking number, 125%. What this really translates into is that the test can't be 20% less than the reference statistically and the reference can't be 20% less than the test. Those are our two tests. That's why we often refer to it as 20% difference in either direction yet the confidence interval bounds don't seem to look like that.
 
2012-10-06 07:50:06 PM  

midigod: justtray: Some company cheated. They had a different product packaged and labelled incorrectly. That's why it's pulled. When you by Advil, you are getting Ibuprofen. Advil is the Brand, Ibuprofen is the generic. When you buy Joe's offbrand Ibuprofen, you are getting the same thing as Advil. In this particular case, they were not, and thus they pulled the product from the shelf correctly.

Thank you for correctly showing that subby must be related to Jenny McCarthy.


seriously? This is what you morons got from the article? The brand name and generic are identical drugs, in identical quantities. Nobody "cheated", whatever the the hell that means. But these are extended release drugs, which means the drug is combined with other fillers designed to spread absorbtion out over a longer period of time. It turns out the 150mg generic release pattern is identical to name brand, but the 300mg release pattern is not.

If you were literate enough to read the article, the comparison with advil is not that the generic doesn't contain ibuprofen. Its that the name brand is like taking an ibuprofen pill every 2 hours for 16 hours. The generic is like taking 8 ibuprofen pills at the same time. Its exactly the same drug, in exactly the same quantity, but the results are very different.

Anyhow, I'm guessing the FDA is going to revise their testing procedures for extended release drugs. And I'm guessing that anyone who compares this to that stupid autism twunt Jenny McCarthy is pretty damned stupid.
 
2012-10-06 08:01:16 PM  

BigLuca: xmasbaby:
Or would you simply take the formula you've already spent hundreds of millions of dollars developing and testing and make sure that your generic equivalent has 80% of the bioavailability by putting in a 80% of the original formulation? (assume a conscienceless team of drug company executives) That would be a perfectly legal way to achieve 80% bioavailablity while maximizing your profits and keeping a market for your tradename drug.

I'm not saying that all generic drugs are crap, but I am saying that if you b ...

I have no idea where you are this 80% from. Did you post a link? I can almost guarantee you that is not true. The only thing I can possible think of is that you are confusion a confidence interval which is commonly held at 80% for many equivalency studies. But that does NOT mean that they just have to be within 80% of active ingredient. Furthermore, the generic manufactures are held to the same standard of accuracy as the brand manufactures. As many people in the thread have stated the only significant difference between brand and generic is (maybe) rate of absorption. And even that is usually negligible.


I was just reading the same thing. I had always heard the "80% bioequivalency" but had never drilled down to see where that came from. Thank you for your effort and patience. I learned something out of all this.
 
2012-10-06 08:10:24 PM  

BigLuca: So the original drug manufacture "tweaks" the formula a bit (usually making a left or right only version, or a new salt of the original drug) and applies for a patent on the "new" drug. Then they get a new 20 year period of exclusivity on this new drug.


Or they do like Wyeth did with Effexor - synthesize the primary metabolite and patent/sell it as a completely new drug (Pristiq). Never mind that it's less effective.
 
2012-10-06 08:23:30 PM  

the801: i'm happy to say that wellbutrin has really changed my life for the better. wow.


Were you on the Teva extended-release formulation? I take it in the winter in the Pacfic NW for seasonal affective symptoms, including some measurable ones such as the tendency to sleep 10-11 hours a day instead of 8. Based on my experience, this article is not BS. The generic Teva extended-release bupropion tablets were wildly inconsistent. One month's refill would work well, the next month's refill would do nothing at all for me. And the month after that, it might work again, but cause strange side effects from tremors to dizziness.

The impression I had was similar to what Ivandrago says -- the active ingredient was chemically equivalent, but the time-release characteristics, including the total quantity delivered, were poorly controlled by the manufacturer. I've seen almost none of the same problems on the Anchen generic that my pharmacy started carrying a year or so ago.

Wellbutrin is underrated as a nootropic-like drug, in my opinion. If you take it for any reason at all, it's worth getting the good stuff, and that means avoiding anything from Teva.
 
2012-10-06 08:25:21 PM  

Morgellons: But since buproprion is such a godawful drug, you need to slow down absorption as much as possible due to GI upset and suicidal thoughts from too much of it in your system at once.


Bupropion is not an SSRI, and is not generally a "godawful drug," whatever that means. Its biggest area of concern is that it lowers the seizure threshold. Inconsistent dosage is a real problem, and based on my experience with the Teva generic that I just mentioned, the FDA is right in this case.
 
2012-10-06 08:34:26 PM  

Morgellons: In case TFA isn't clear, the problem was specifically with the extended-release mechanism. This has been a known problem since Wellbutrin XL came off patent.

In most extended-release formulations, the rate at which drug is released is remarkably irrelevant. But since buproprion is such a godawful drug, you need to slow down absorption as much as possible due to GI upset and suicidal thoughts from too much of it in your system at once.

Basically, if you're on buproprion (Or for that matter venlafaxine/Effexor), tell your shrink to switch you to something else. I've never had anyone come in to my pharmacy and say "Wow, this Wellbutrin has really changed my life for the better!"; it's always to the contrary.

Also, there is the unspoken "rule" in psych meds of sticking to one manufacturer once you're stable.

/SO freaking glad I'm in nuclear pharma now so I don't have to deal with this crap.


That's so stupid I don't even know where to start.
 
2012-10-06 08:40:03 PM  

xmasbaby: BigLuca: xmasbaby:
Or would you simply take the formula you've already spent hundreds of millions of dollars developing and testing and make sure that your generic equivalent has 80% of the bioavailability by putting in a 80% of the original formulation? (assume a conscienceless team of drug company executives) That would be a perfectly legal way to achieve 80% bioavailablity while maximizing your profits and keeping a market for your tradename drug.

I'm not saying that all generic drugs are crap, but I am saying that if you b ...

I have no idea where you are this 80% from. Did you post a link? I can almost guarantee you that is not true. The only thing I can possible think of is that you are confusion a confidence interval which is commonly held at 80% for many equivalency studies. But that does NOT mean that they just have to be within 80% of active ingredient. Furthermore, the generic manufactures are held to the same standard of accuracy as the brand manufactures. As many people in the thread have stated the only significant difference between brand and generic is (maybe) rate of absorption. And even that is usually negligible.

I was just reading the same thing. I had always heard the "80% bioequivalency" but had never drilled down to see where that came from. Thank you for your effort and patience. I learned something out of all this.


No problem. That is what I like about Fark, people are more mature and there is an actual exchange of information. Well, usually. Sometimes. Outside of the politics tab at least.
 
2012-10-06 08:49:11 PM  
One of the reasons I am still alive twenty years after a liver transplant is because I take an immunosuppressant, Prograf. There is a generic version on the market. Prograf is about $260 per month. The generic from India is about $250 per month. My drug store substituted the generic one month because they ran out of the name brand. In the following month my liver was rejected by my immune system causing me grievous pain and potentially killing me. I object to this.
I am not saying generic should be banned but that ALL of them should be tested for the same stuff as the original. That will make them more expensive. I don't want to die over ten bucks.
 
2012-10-06 09:00:38 PM  

xmasbaby: There's a widespread belief that big drug companies that sell expensive drugs like Prozac, Percocet, and Valium are somehow evil and conniving, but somehow the companies who make and sell the generics get a pass.

Please take a moment to read about generic drugs. There are many good sources out there including the FDA and even wikipedia's section is solid. Generic drugs have been marketed as "the same" and "just as good as" trade name drugs, but the phrase I want you to look for is "The FDA requires the bioequivalence of the generic product to be at least 80% of that of the innovator product."

In reality, the cheapest and easiest way to make a generic drug is to start with 20% less of the active ingredient.

That phrase is why people who regularly take Percocet and Valium tend to ask for the "trade name" version of the drug. They frequently are getting only ~20% of the effect they have grown to expect. You can't sense this in an antibiotic or a anti-hypertensive, but you can in "nerve pills" and pain pills.

As an anesthesiologist in training, I used to administer a muscle relaxant called Norcuron whose active ingredient was vercuronium. I would give a milligram or two intravenously, and by measuring the patient's response to the drug by electrical stimulation would know when the drug wore off. Then we switched to generic Vercurionum. It quickly became apparent that we needed to use a lot a more of the generic stuff than than the name brand stuff. That got me interested in what the term "generic" meant medically. It turned out to be a legal definition.

Personally, when it's me or my family, and it's a serious problem, I try to get the name brand version of the drug. Remember, when something sounds too good to be true, it sometimes is.

/loves me the giant generic jug of ibuprofen, but sometimes need to take three.


Yeah.. no. Try researching that again. Specifically read 21 CFR parts 210 and 211. In it you will find that it is absolutly illegal to formulate your drugs to anything less than 100% potency. There is absolutely no way that a batch record for a formulation with less than 100% of the required active ingredient would make it past ANDA review.
The 20% you refer to, and so many people wrongly apply concerns certain data from biostudies. It isn't particularly important what this data is, but the 20% variability is what you would expect from comparing multiple lots of the innovator product. What the 20% rule of thumb boils down to is that your generic formulation will be as variable in biostudy as the brand product.

I work in generic drug quality. I know of what I speak. Many of the websites that proport to provide "knowledge" or "secrets" about generics either have no idea about 21 CFR or even worse have taken certain FDA guidance documents had have intentionally misinterpreted them to fit their ends.

Now, about your experience with vancuronium, did you report this to medwatch or the manufacturer? Lack of effect is a serious complaint that would result in an investigation by the firm. Please note that this isn't an "investigation" but a real genuine examination of the product and lots in question. If you were previously administering 1mg and now you have to administer 3 to get the same results, you should have filed a complaint. I urge you to do so, for the safety of your patients.

With all this being said, I still won't take any generics from certain manufacturers. Mainly south asian firms.
 
2012-10-06 09:07:58 PM  

ausfahrk: It sounds like your pharmacy is built wrong. You should have one guy shoving pills into bottles, one guy telling people to go fark themselves, and one guy answering the phone.


No, just some pharmacies can't afford the staffing that walgreens and riteaid have. Heck I worked at target for years and it was just a pharmacist and I. sometimes just the pharmacist. we needed and wanted more staff, but that wasn't our call. In any event, I'm in hospital pharmacy now so it's water under the bridge.

now I get to deal with crack wh***s in the ER who are there because they're out of crack because they couldn't find anyone's c**k to suck to get money to buy more crack. good times good times.
 
2012-10-06 09:19:26 PM  

CWeinerWV: Morgellons: In case TFA isn't clear, the problem was specifically with the extended-release mechanism. This has been a known problem since Wellbutrin XL came off patent.

In most extended-release formulations, the rate at which drug is released is remarkably irrelevant. But since buproprion is such a godawful drug, you need to slow down absorption as much as possible due to GI upset and suicidal thoughts from too much of it in your system at once.

Basically, if you're on buproprion (Or for that matter venlafaxine/Effexor), tell your shrink to switch you to something else. I've never had anyone come in to my pharmacy and say "Wow, this Wellbutrin has really changed my life for the better!"; it's always to the contrary.

Also, there is the unspoken "rule" in psych meds of sticking to one manufacturer once you're stable.

/SO freaking glad I'm in nuclear pharma now so I don't have to deal with this crap.

That's so stupid I don't even know where to start.



Well please, for my benefit, start somewhere. I'd really love to know where I'm being stupid. I only have what I've seen in retail and hospital pharmacy to go by, so I can only benefit from your knowledge.

Man On Pink Corner: Morgellons: But since buproprion is such a godawful drug, you need to slow down absorption as much as possible due to GI upset and suicidal thoughts from too much of it in your system at once.

Bupropion is not an SSRI, and is not generally a "godawful drug," whatever that means. Its biggest area of concern is that it lowers the seizure threshold. Inconsistent dosage is a real problem, and based on my experience with the Teva generic that I just mentioned, the FDA is right in this case.


I never said it was an SSRI, and by "godawful" I mean the side effects are worse than the benefit, for most patients I've seen. And I agree the FDA was right in suggesting Teva pull Budeprion XL from the market. If you or a loved one have actually benefited from bupropion, then mazel tov. Would I ask for it first-line? No, but then again I'm not a shrink.

And I suppose I do owe xmasbaby a small apology, I came on a little heavy-handed, and am only perpetuating the stereotype that pharmacists and anasthaesiologists cannot get along. (But don't get me started on Demerol...)
 
2012-10-06 09:24:31 PM  

Morgellons: In case TFA isn't clear, the problem was specifically with the extended-release mechanism. This has been a known problem since Wellbutrin XL came off patent.

In most extended-release formulations, the rate at which drug is released is remarkably irrelevant. But since buproprion is such a godawful drug, you need to slow down absorption as much as possible due to GI upset and suicidal thoughts from too much of it in your system at once.

Basically, if you're on buproprion (Or for that matter venlafaxine/Effexor), tell your shrink to switch you to something else. I've never had anyone come in to my pharmacy and say "Wow, this Wellbutrin has really changed my life for the better!"; it's always to the contrary.

Also, there is the unspoken "rule" in psych meds of sticking to one manufacturer once you're stable.

/SO freaking glad I'm in nuclear pharma now so I don't have to deal with this crap.


If it would make you feel better about it, I could come and tell you. Effexor saved my life. Lexapro allowed me to sit still (and no longer get the daily headaches one hour before I was supposed to take my dose or have weird chin quivers), Wellbutrin allowed me to actually live. I get stuff done, I am actually happy (it had been a very long time since I was truly happy and content), I can sit still and don't make shadow puppets at research symposiums (hey, the professors thought it was hilarious when they spotted me (it was during a break)). No, it's not a perfect miracle drug, but it has honestly made a huge positive impact on my life. So here: Wow, this Wellbutrin has really changed my life for the better!
 
2012-10-06 09:45:21 PM  

Morgellons: And I suppose I do owe xmasbaby a small apology, I came on a little heavy-handed, and am only perpetuating the stereotype that pharmacists and anasthaesiologists cannot get along. (But don't get me started on Demerol...)


It's only a stereotype because it's true... :)

And... what's "demoral"? Is it anything like fentanyl and morphine? Or is it more like benadryl, robitussin and atropine?

/not at all biased!
 
2012-10-06 09:58:56 PM  
You're saying that if you label something "40 mg oxycodone" it doesn't have to contain 40 mg of oxycodone?! That would make drugs the only consumer good in existence where you could deliberately mislabel. Try doing that with a bottle of water and the FTC will fine you out of existence.

I'm not sure about oxycodone but lumber is ALL mislabeled. A 2 X 4 is not even close to being 2 X 4. It's only 1.5 X 3.5, maybe smaller still since a friend of mine said they shrank again. A 2 X 4 has 8 square inches of cross section. 1.5 X 3.5 equals 5.25 square inches. That's only 66% as big and that really matters. You are getting ONE THIRD LESS than you paid for. Yeah yeah, everybody knows you're getting cheated with lumber, why not drugs?
Not trolling, just setting the record straight.
 
2012-10-06 10:04:49 PM  

Chucklz: xmasbaby: There's a widespread belief that big drug companies that sell expensive drugs like Prozac, Percocet, and Valium are somehow evil and conniving, but somehow the companies who make and sell the generics get a pass.

Please take a moment to read about generic drugs. There are many good sources out there including the FDA and even wikipedia's section is solid. Generic drugs have been marketed as "the same" and "just as good as" trade name drugs, but the phrase I want you to look for is "The FDA requires the bioequivalence of the generic product to be at least 80% of that of the innovator product."

In reality, the cheapest and easiest way to make a generic drug is to start with 20% less of the active ingredient.

That phrase is why people who regularly take Percocet and Valium tend to ask for the "trade name" version of the drug. They frequently are getting only ~20% of the effect they have grown to expect. You can't sense this in an antibiotic or a anti-hypertensive, but you can in "nerve pills" and pain pills.

As an anesthesiologist in training, I used to administer a muscle relaxant called Norcuron whose active ingredient was vercuronium. I would give a milligram or two intravenously, and by measuring the patient's response to the drug by electrical stimulation would know when the drug wore off. Then we switched to generic Vercurionum. It quickly became apparent that we needed to use a lot a more of the generic stuff than than the name brand stuff. That got me interested in what the term "generic" meant medically. It turned out to be a legal definition.

Personally, when it's me or my family, and it's a serious problem, I try to get the name brand version of the drug. Remember, when something sounds too good to be true, it sometimes is.

/loves me the giant generic jug of ibuprofen, but sometimes need to take three.

Yeah.. no. Try researching that again. Specifically read 21 CFR parts 210 and 211. In it you will find that it is absolutly i ...


That is really interesting. Thank you for taking the time to correct my misconception. I wasn't aware of 21 CFR parts 210 and 211, but knowing that will allow me to avoid embarrassment the next time I go off on a similar rant.

I don't understand the mystery of the weak Vecuronium, but the generic stuff never worked as well as the brand name stuff, and that was with us performing informal studies daily as we titrated to our "train of four" effect. Honestly, it never occurred to me to report it or investigate it. As a resident, survival was my primary concern, and when our behemoth hospital changed to a weaker version of the drug, we just rolled with it as another inconvenience of being a trainee.

As an aside, another incident that I should have reported but was too busy working all night from one case to the next, involved removing a Philadelphia collar from a MVA trauma to discover that someone had stuffed a STACK of a personal injury lawyer's business cards under the collar! That was outrageous, irresponsible and dangerous, but there was no way of knowing who it it.

Anyway, thank you for educating me and correcting me on the subject generic drugs. I still have a bias against them based on my personal experiences, but recognize that is not "evidence based" and I do try to keep an open mind and accept when I am mistaken. Thank you.
 
2012-10-06 10:34:38 PM  

OhLuverly: You come to the counter. I am on the phone with a drunk dude who wants the phone number to the grocery store next door. After I instruct him on the virtues of 411, you tell me your doctor was to phone in your prescription to me. Your doctor hasn't, and you're unwilling to wait until he does. Being in a generous mood, I call your doctors office and am put on hold for 5 minutes, then informed that your prescription was phoned in to my competitor on the other side of town. Phoning the competitor, I am immediately put on hold for 5 minutes before speaking to a clerk, who puts me back on hold to wait for the pharmacist. Your prescription is then transferred to me, and now I have to get the 2 phone calls that have been put on hold while this was being done. Now I return to the counter to ask if we've ever filled prescriptions for you before. For some reason, you think that "for you" means "for your cousin" and you answer my question with a "yes", whereupon I go the computer and see you are not on file.

The phone rings.

You have left to do something very important, such as browse through the monster truck magazines, and do not hear the three PA announcements requesting that you return to the pharmacy. You return eventually, expecting to pick up the finished prescription.....

The phone rings.

......only to find out that I need to ask your address, phone number, date of birth, if you have any allergies and insurance coverage. You tell me you're allergic to codeine. Since the prescription is for Vicodin I ask you what exactly codeine did to you when you took it. You say it made your stomach hurt and I roll my eyes and write down "no known allergies" You tell me......

The phone rings.

.....you have insurance and spend the next 5 minutes looking for your card. You give up and expect me to be able to file your claim anyway. I call my competitor and am immediately put on hold. Upon reaching a human, I ask them what insurance they have on file for you. I get the information and file your claim, which is rejected because you changed jobs 6 months ago. An a-hole barges his way to the counter to ask where the bread is.

The phone rings.

I inform you that the insurance the other pharmacy has on file for you isn't working. You produce a card in under 10 seconds that you seemed to be unable to find before. What you were really doing was hoping your old insurance would still work because it had a lower copay. Your new card prominently displays the logo of Nebraska Blue Cross, and although Nebraska Blue cross does in fact handle millions of prescription claims every day, for the group you belong to, the claim should go to a company called Caremark, whose logo is nowhere on the card.

The phone rings.

A lady comes to the counter wanting to know why the cherry flavored antacid works better than the lemon cream flavored antacid. What probably happened is that she had a milder case of heartburn when she took the cherry flavored brand, as they both use the exact same ingredient in the same strength. She will not be satisfied though until I confirm her belief that the cherry flavored brand is the superior product. I file your claim with Caremark, who rejects it because you had a 30 day supply of Vicodin filled 15 days ago at another pharmacy. You swear to me on your mother's'....

The phone rings.

.......life that you did not have a Vicodin prescription filled recently. I call Caremark and am immediately placed on hold. The most beautiful woman on the planet walks buy and notices not a thing. She has never talked to a pharmacist and never will. Upon reaching a human at Caremark, I am informed that the Vicodin prescription was indeed filled at another of my competitors. When I tell you this, you say you got hydrocodone there, not Vicodin. Another little part of me dies.

The phone rings.

It turns out that a few days after your doctor wrote your last prescription, he told you to take it more frequently, meaning that what Caremark thought was a 30-day supply is indeed a 15 day supply with the new instructions. I call your doctor's office to confirm this and am immediately placed on hold. I call Caremark to get an override and am immediately placed on hold. My laser printer has a paper jam. It's time for my pharmacy tech to go to lunch. Caremark issues the override and your claim goes though. Your insurance saves you 85 cents off the regular price of the prescription.

The phone rings.

At the cash register you sign....

The phone rings.

......the acknowledgement that you received a copy of my HIPAA policy and that I offered the required OBRA counseling for new prescriptions. You remark that you're glad that your last pharmacist told you you shouldn't take over the counter Tylenol along with the Vicodin, and that the acetaminophen you're taking instead seems to be working pretty well. I break the news to you that Tylenol is simply a brand name for acetaminophen and you don't believe me. You fumble around for 2 minutes looking for your checkbook and spend another 2 minutes making out a check for four dollars and sixty seven cents. You ask why the tablets look different than those you got at the other pharmacy. I explain that they are from a different manufacturer. Tomorrow you'll be back to tell me they don't work as well.

Now imagine this wasn't you at all, but the person who dropped off their prescription three people ahead of you, and you'll start to have an idea why.....your prescription takes so damn long to fill.

Link


This is a work of art.
 
2012-10-06 10:42:12 PM  
S O B's. Bought and paid for by the companies it's supposed to be keeping a leash on.

I think we need a third party company set up to provide truly random tests on generic as well as brand drugs. I'm a pharmacist and I'm really tired of telling people generics are legally, chemically the same, then having this kind of shiat happen. And Teva ain't some mom and pop operation, it's massive.
 
2012-10-06 10:53:14 PM  

lethological_lassie: This is a work of art.


Indeed, and if it doesn't scare pharmacy students, it should. It looks like their job depends entirely on the lack of adequate bioinformatics. If someone ever manages to fix that, it will be "disruptive to the industry," to put it mildly.
 
2012-10-06 10:56:20 PM  

Morgellons: If you or a loved one have actually benefited from bupropion, then mazel tov.


Question -- are you judging the risks and benefits of buproprion on the basis of prescriptions you've filled for the Teva generic?

Because this particular debate has been going on for quite a few years now. Patients have been complaining about Teva's product for at least five years.
 
2012-10-07 12:16:39 AM  

lennavan: It could cost us tens of billions of dollars because this one single case will be trumpeted by the makers of name brand drugs as a shining beacon of why name brand drugs are better. And a portion of the country will be swayed, for instance everyone on Wellbutrin, right? Put another way - this example coupled with the stupidity of the country will indeed cost us billions. And the name brand drug makers will indeed spin the farking hell out of this.


That's exactly what I'm afraid of. All of the money saved, and effort we've put into getting people onto generics faces a threat with this kind of finding from the FDA. People (patients) really don't understand this as a one-off, or even 1 or 2 other manufacturers of just the bupropion. I already have to promise patients that what we are giving them is equivalent, and they are wary making the change.

Hopefully, the media doesn't run with it, but brand name manufacturers will do their best to use it to keep patients on their pricier meds.
 
2012-10-07 02:15:34 PM  
I think there are about a half dozen people in here who are supposed to be filling out safety reports now. ;-)
 
2012-10-08 11:27:42 AM  

Freudian_slipknot: office_despot: One of my colleagues is taking Synthroid, and refuses the generic because the same kinds of "rumors" from users are out there concerning its effectiveness. Our insurance won't pay for name-brand Synthroid, so he pays out of pocket for it. I wonder whether the FDA will look into that, too.

Also, regarding birth control, I don't even remember which option this was or whether it was a Teva drug, it was so long ago, but at one point the gynecologist gave me a long explanation of why the generic version of one drug was not actually the same as the more expensive name brand. I figure the doctor ought to know.

Actually, that's true about levothyroxine, the drug in Synthroid. There are several generics out there, and switching between them is hugely problematic because the drug is measured in micrograms and there can actually be a difference in effective medicine between the different generics vs the name brand. Also, different people have different reactions to the non-active ingredients used in the different versions that can affect uptake.

That said, once you're on a generic that you tolerate well and you get your levels properly checked you should be fine continuing on that brand of generic. The problem comes in if you have to switch pharmacies and they carry the generics manufactured by a different company that might contain a slightly different dose or different inactive ingredients.

/at least that's what the endocrinologists tell me
//including the one I was dating last year
///total thyroidectomies are superfun!


I take a generic of Synthroid, but I don't worry about it because I have to have my thyroid levels checked every three months. I figure if the drug wasn't working my doctor would have figured it out by now.
 
2012-10-08 11:48:28 AM  

PastaFazoole: I take a generic of Synthroid, but I don't worry about it because I have to have my thyroid levels checked every three months. I figure if the drug wasn't working my doctor would have figured it out by now.


That's the way to do it. You can take the generic you just need to go back through and have your levels tested to make sure it's working. Synthroid is one of the few drugs that if a patient is on brand we will not switch to generic without the doctor's/patient's ok because the therapeutic window is so small and it does require a lot of testing (we wont even sub out between generic manufactures its so small. If you're on teva you stay on teva, if you're on watson you stay on watson etc) Only other drug I can think of off the top of my head would be anti-seizure at which point most pharmacists I know will not switch to generic even if the doc says it ok. No one wants to be liable for someone having a seizure.
 
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