Banning "Me-Too" Follow-On Drug Treatments Is The Right Answer

[roo_ster]

Or, maybe not:
http://www.theatlantic.com/business/archive/2011/01/me-too-drugs-herd-animals-not-copycats/70269/

Essentially, the socialized-medicine folks think that follow-on drugs (in the wake of pioneering drugs) are a harmful duplication, waste development resources, and just make a minor tweak to the pioneer after they see the pioneer is successful.  When we have single-payer, we'll eliminate that "inefficiency."

Well, that is not the case, and banning or limiting them is asinine.  The drug development cycle is 10+ years.  The first follow-on drugs nowadays appear, on average, 1.7 years after the pioneer.  Do the math.  You have an idea that might work that several companies are simultaneously working to develop a drug.  Somebody is going to be first to market.

Also, some drugs that work in a similar manner work better for some people than others.  Very first comment:
"The whole subject upsets me. Aside from everything Megan said: My wife has suffered from bipolar disorder for almost two decades, trying one drug after another. Some made her sick, some made her gain vast amounts of weight, some she couldn't get out of bed, some just didn't help. She has used well over a dozen different drugs. This last year we tried yet one more. It worked great, with no side effects we can see, and she has been a whole year without a major problem.

Anyone who is against me-too drugs doesn't understand medicine. They are an important part of the incredible story of modern medical advancement. "

[41magsnub]

Yep.  I tried a different generic of one of my medications and it worked massively better than the original one at the same dosage.

[BridgeRunner]

Yep.  I tried a different generic of one of my medications and it worked massively better than the original one at the same dosage.

Same here, except the second generic had much more tolerable side effects.

[French G.]

Pharma rant.  Listen here. Big pharma is evil. They'll try to tell you that due to an asinine amount of regulation it takes a billion dollars to bring a drug to market. They will attempt to rationalize that in most of the world they sell their drugs at near cost due to socialized extortion medical wonderhappyjoyfulness. Then they'll whine that due to weak patent laws they have a limited time to make money on their work. That's just a lie, they just want moar money from all you feeble cripples. 

I've personally seen the difference in same class anti-depressants having dramatically not same results in the patient. But we're from the gov't, you'll take what drugs are good for you peasant. We'll tell you what those are too BTW.

[KD5NRH]

Yep.  I tried a different generic of one of my medications and it worked massively better than the original one at the same dosage.

Heck, aspirin, of all things, ought to be pretty constant and simple; active ingredient and a cornstarch filler, maybe a binder or a coating.  Bayer works for me, HEB's generic too.  Equate (WalMart generic) just gives me heartburn, with no pain or fever mitigation.

[brimic]

Heck, aspirin, of all things, ought to be pretty constant and simple; active ingredient and a cornstarch filler, maybe a binder or a coating.

The ingredients can be the same but the formulation can be vastly different. The crystalline structure of an Active pharmaceutical Ingredient (API) can vary, the particles can be be of different sizes, coatings vary, as well as a large number of different manufacturing parameters- all of which can change how the drug interacts with an individual's body.

[GigaBuist]

Maybe I mis-understood the OP but I don't think it's the generics that they've got a problem with.  It's stuff like Zoloft being created when we had another SSRI (Prozac) on the market.  Or Cialis when Viagra is out and about.  Things like that.

[Pharmacology]

Ridiculous!!

Creating "Me-too" drugs is a basic necessity of advancing drugs!

I could go on all day long about big advances that have been made because of "me too" drugs.

Fondaparinux and enoxaparin,  the ACE inhibitors, etc!

Same here, except the second generic had much more tolerable side effects.

With regards to mechanism of action,  crystalline structure of "api" etc...   The effects of crystalline structure on solubility of the drug/it's pharmacological effects/onset of action/duration of action are taken care of during the drug development process.  There's a reason so much research goes into it.

Unless the drug you're talking about was levothyroxine, the differences are probably all in your head.

Pharma rant.  Listen here. Big pharma is evil. They'll try to tell you that due to an asinine amount of regulation it takes a billion dollars to bring a drug to market. They will attempt to rationalize that in most of the world they sell their drugs at near cost due to socialized extortion medical wonderhappyjoyfulness. Then they'll whine that due to weak patent laws they have a limited time to make money on their work. That's just a lie, they just want moar money from all you feeble cripples.  rolleyes

I've personally seen the difference in same class anti-depressants having dramatically not same results in the patient. But we're from the gov't, you'll take what drugs are good for you peasant. We'll tell you what those are too BTW.

1.)  It doesn't take a billion dollars.   It takes approx. 800 million dollars to introduce 1 new drug.

2.) Unless you're talking about places like India, I don't think you understand the issue.  

http://www.nejm.org/doi/full/10.1056/NEJMp048158
I suppose you're going to claim NEJM is a pawn of "big pharma"     ( To be clear, I'm posting that article because it accurately describes how things work now. I am not agreeing with the author's conjecture.)


3.) Making a statement based on the effects of an "anti-depressant" in two individuals without regards to dose, indication, or diagnosis is simply a non argument.

 The amount of counterfeit drugs produced in India and other places is a serious problem, and if you'd like to start taking drugs manufactured in India, be my guest.  Just know that no competent pharmacist will ever recommend buying drugs from those third world-esque manufacturers.


Also, inb4 "buy the drugs from Canada."  Buying drugs from Canada is a farce, because .ca acts as a gateway for drugs from less desirable sources.
All of those people buying "Canadian" drugs via online pharmacies are taking medicines that no Canadian manufacturer ever touched.  They're imported into canada from other countries for sale into the US and other markets.
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GigaBuist is spot on, you guys aren't understanding the "me too" concept.

Generic drugs are the result of a patent expiring on a new, exciting drug.   After the patent expires, anyone can make the generic. It is the exact same chemical compound.

Me too drugs are sneakier.  They take the original drug,  and change a group on the drug molecule, which can sometimes be a minute change to the functional groups of the pharmacophore or surrounding structure.


Take the ACE inhibitors for example:

http://media.wiley.com/CurrentProtocols/PH/ph0901/ph0901-fig-0006-1-full.gif

Those are three different drugs

[BridgeRunner]

Unless the drug you're talking about was levothyroxine, the differences are probably all in your head.

Yeah, uh-huh.  

No, they are not exactly the same.  They use identical chemicals as their active ingredients.  That is not the same thing as being identical.  I'm talking about Adderall, which has very profound effects that occur very quickly, and it is entirely plausible that me and all the other people who have problems with one brand or another of Adderall are not actually just suffering from overactive imaginations, but from significant differences in which compounds are absorbed at what time.  

Giga--yeah, I know, i was just jumping on the bandwagon.  Although, it does seem to me that pharmacuetical companies would do well to investigate differences reported widely in different generics, as documenting that information could lead to improved formulations.  Instead, standard practice is to deny that there is any difference at all.

[Pharmacology]

Yeah, uh-huh.  
No, they are not exactly the same.  They use identical chemicals as their active ingredients.  That is not the same thing as being identical.  I'm talking about Adderall, which has very profound effects that occur very quickly, and it is entirely plausible that me and all the other people who have problems with one brand or another of Adderall are not actually just suffering from overactive imaginations, but from significant differences in which compounds are absorbed at what time.  

Giga--yeah, I know, i was just jumping on the bandwagon.  Although, it does seem to me that pharmacuetical companies would do well to investigate differences reported widely in different generics, as documenting that information could lead to improved formulations.  Instead, standard practice is to deny that there is any difference at all.

Yes, they are exactly the same with regards to the pharmacologically significant portions. The excipients have no pharmacological activity related to the therapeutic effect of the drug.
You're not going to experience tachycardia or CNS side effects due to the excipients.
With regards to "compounds" being absorbed, the proteins in your blood have more to do with that than the excipients.

Let me put it to you this way:  Before a drug can be absorbed it has to go into solution. That is where excipients play a key role. In this case, they have little to do with free plasma concentrations, which is what I gather you mean by  "absorbed"
You could be allergic (rash,  to the excipients, in which case you should contact your health care providers.  Your kidneys could be working poorly.  You could've be taking them with a citrus juice, which might effect the drug.
Now, another explanation might be that they switched you from Adderal to Adderal XR.

There are a million possible explanations.  "Big pharma conspiracy to avoid spending money on why excipients interfere with bioequivalence" is not one of those explanations.
But, if you can somehow prove how lactitol, microcrystalline cellulose, colloid SiO2, and Mg stearate have clinically significant effects on the central nervous system, then you'd better start sending in applications as a 1337 researcher.


P.S. Adderal and generic appear to have the exact same excipients.

[MicroBalrog]

So, how does this do anything but make the manufacturer of the original drug even wealthier?

Imagine we banned 'me-too follow-on televisions'. After all Toshiba already makes LCD flat screens. Why would we want to duplicate research and have, say, Metz also produce flatscreens? Huh? Huh?

[brimic]

Generic drugs are the result of a patent expiring on a new, exciting drug.   After the patent expires, anyone can make the generic. It is the exact same chemical compound.

Yes and no.
A drug whose patent is going to expire will spark other entities to produce it. The first entity to get the generic on the market gets exclusivity for making the generic for a period of time. Not only that but if the original drug were an important money maker, the original maker will often file new patents on the drug, whether it be for new indications or for critical reactions in making the drug.

[BridgeRunner]

Yeah, Pharma, that's exactly it, I just oops, got switched to a different drug that last twice as long, is in a different form, and has a different dosage, but I didn't notice, oops, no wonder I feel different.

You do perhaps realize that "not a pharmacist" and "stupid" are not the same thing?  Your own incredibly condescending and arrogant attempt to state why I'm wrong (and apparently stupid) completely fails to address the issue I mentioned.  Moreover, I didn't invent this; I learned of it from a range of credible sources after I experienced the problem. 

Finally: Get over yourself.  I'm pretty sure you're not impressing anyone. 

[Bogie]

Hi there...
 
I used to be a druggie.
 
It may cost $800,000,000 to a billion dollars to...
 
Produce a drug
 
or
 
Build an assembly line for a new vehicle
 
At least when you're doing an assembly line, you KNOW you'll get at least one car...
 
I saw drugs make it into human trials, and then get scrapped. This was AFTER beaucoup major money had been spent on them.
 
The "second gens" can be very nice. I was on the development team for Celebrex. Great stuff. Bextra, however, worked much better on my joint pain. Then Merck cut a buncha corners with it's cyclooxygenase-II inhibitor, and the FDA was gonna yank the entire class. So Pfizer gave 'em Bextra (which should have basically just had a black-box allergy warning). Sigh.
 
Politics.
 

[French G.]

1.)  It doesn't take a billion dollars.   It takes approx. 800 million dollars to introduce 1 new drug.

2.) Unless you're talking about places like India, I don't think you understand the issue.  

http://www.nejm.org/doi/full/10.1056/NEJMp048158
I suppose you're going to claim NEJM is a pawn of "big pharma"     ( To be clear, I'm posting that article because it accurately describes how things work now. I am not agreeing with the author's conjecture.)


3.) Making a statement based on the effects of an "anti-depressant" in two individuals without regards to dose, indication, or diagnosis is simply a non argument.

 The amount of counterfeit drugs produced in India and other places is a serious problem, and if you'd like to start taking drugs manufactured in India, be my guest.  Just know that no competent pharmacist will ever recommend buying drugs from those third world-esque manufacturers.


Also, inb4 "buy the drugs from Canada."  Buying drugs from Canada is a farce, because .ca acts as a gateway for drugs from less desirable sources.
All of those people buying "Canadian" drugs via online pharmacies are taking medicines that no Canadian manufacturer ever touched.  They're imported into canada from other countries for sale into the US and other markets.
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GigaBuist is spot on, you guys aren't understanding the "me too" concept.

Ok, take a deep breath. That was satire except for the part about two near identical drugs affecting my wife differently. Hell, I was there. The rest, my take on how the perpetually outraged see pharma. Sorry my numbers were outdated, been a few years since I followed pharma stocks. What's .2 billion among friends anyway? Have a chill pill.

[Pharmacology]

Ok, take a deep breath. That was satire except for the part about two near identical drugs affecting my wife differently. Hell, I was there. The rest, my take on how the perpetually outraged see pharma. Sorry my numbers were outdated, been a few years since I followed pharma stocks. What's .2 billion among friends anyway? Have a chill pill.

Sorry, I made a C on the exam in the public relations section in public health. My first point was an attempt at humor (.8 bil vs 1 bil), and re-reading it, I see the obvious satire.
Jeez, I seem to be losing my reading comprehension skills all of the sudden.    Maybe it's all of the late nights studying therapeutics.

I think I'll just stop making serious posts , even if I am the only expert on the subject on APS.

[roo_ster]

Sorry, I made a C on the exam in the public relations section in public health. My first point was an attempt at humor (.8 bil vs 1 bil), and re-reading it, I see the obvious satire.
Jeez, I seem to be losing my reading comprehension skills all of the sudden.    Maybe it's all of the late nights studying therapeutics.

I think I'll just stop making serious posts , even if I am the only expert on the subject on APS.

FTR, the OP title is satire/sarcasm/etc.  I don't think banning them is a bad idea.

 

[Pharmacology]

FTR, the OP title is satire/sarcasm/etc.  I don't think banning them is a bad idea.
 

That one, thankfully, I did catch 

Honestly, though, I'm glad someone's calling me out on my ass-hat-ery!