Name-brand drugs vs. generics

Cecil's Columns/Staff Reports
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In the article:

Cecil clearly said that there can be differences on non-trivial drugs, between name-brands and generics.

This is quite true as there are more to a drug than just the effective ingredient.

There are carriers, enablers and inhibitors, that facilitate the movement of the effective drug into the right place. These are normaly non-patented secret proprietary chemicals that are not easily copied. So a generic drug can be more ineffecient as it may not enter the right place in suifficient concentration.

This is not case with such drugs as paracetamol or ibuprofen where generics as as good as name-brands.

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It is very hard to get straight dope on dope. Even university studies can no longer be trusted if the medication just happens to be from the company that funds their lab. There is a direct correlation between positive studies and who pays it seems. This isn’t just for medications it’s for the machinery of medicine as well.

The other problem is that buying a non generic doesn’t mean you are getting an American made product, odds are you may still be buying a Chinese made pill or primary ingredient regardless what the final bottle statement says. That was one of the biggest jokes about some people saying we should not be allowed to buy Canadian medications with Medicare or Tricare dollars, you may still getting a Wal-Mart (Chinese) product.

The VA uses generics when ever they can for all of my medications and I have a lot of medications, unfortunately. I suffered a serious accident and some minor ones in the service and have had to change medications but not because of any quality control issues. I have only had to change or adjust medications after spraying machine gun fire… No, wait, I mean for medical reasons.

Seriously, I do generally trust the generic market and believe that most of the attacks on it are a bit like the hubbub about election fraud. Show the facts. Show me some real hard core facts and detailed statistics to show that this is a bigger problem than the problem of over charging for medications. The free market is fine, if there was one but in this case there isn’t. It feels as if we have a false issue to scare people to spend more.

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When a generic drug is approved, the formulation must be as effective as the non-generic drug, not that it necessarily contains the same amount of the medication, but it is as effective as the name-brand drug.

In many cases, the name brand drug and the generic are manufactured on the same assembly line. Sometimes major drug manufacturers make their own generic. Sometimes drug manufacturers will outsource production of both the name brand and generic to a generic manufacturer.

The big difference between a generic and non-generic brand is sometimes the dosage method. The non-generic might include another drug (like ibuprofen) or made in a time release form. Then, the company repatents the drug under the new formulation is a process called evergreening. The company then goes out and explains to doctors why the non-generic is better than the generic and try to get doctors to give the prescription in the non-generic formulation.

In most states, if there’s a generic and non-generic brand of a drug, a pharmacist can dispense either one unless a doctor specifically marks on the script “Do not substitute”. However, if the doctor goes with a formulation that’s unique to the non-generic version, pharmacists must dispense the non-generic version.

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“When a generic drug is approved, the formulation must be as effective as the non-generic drug, not that it necessarily contains the same amount of the medication, but it is as effective as the name-brand drug.”

-not so "To gain FDA approval, a generic drug must:…be identical in strength, dosage form, and route of administration [as the innovator drug]

"In many cases, the name brand drug and the generic are manufactured on the same assembly line. Sometimes major drug manufacturers make their own generic. Sometimes drug manufacturers will outsource production of both the name brand and generic to a generic manufacturer. "

Problems can arise because it is the drug which must meet these standards and not the formulation: 2 formulations of the same medicine by different generic manufacturers may use different (FDA approved) “inactive” ingredients which may hav subtly different effects on how the drug is absorbed. This can be a problem with drugs with a small volume of distribution, or drugs with a narrow window between effective levels and toxic levels such as anti-convulsants

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Here is a real world example of difference: I take a medication daily, the dose of which requires three 30mg capsules, or 90mg of the drug. I recently ran out of all but a few capsules, but had a different bottle of 20mg capsules, still no where near expiration date, sealed bottle, cool dry place, etc.

So I took one 30mg and four 20mg capsules. Wow, what a difference. Just kidding, wanted to make sure you are paying attention. :smiley:

I actually took one 30mg and three 20mg capsules. There was a very real difference in how I felt that day (yes, drug must be some sort of short acting psych. med). It’s a medication that if skipped gives me very specific, peculiar sensations. If I miss my dose by more than half a day, I fell weird, and in fact because I’m absent minded, it’s often that weird feeling that prompts me to take my meds. I got the same sensation, although less strongly, when using what should have added up to 90mg.

I repeated the experiment several times, with same results. Now obviously this isn’t double blind, blah blah, and in both cases I was taking a name brand, not generic. It does illustrate though how just different packaging can alter when and how quickly a drug enters the blood stream. Maybe it was “all in my head”, but in the case of psychiatric medications, even imagined changes can be significant.

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in the infinite wisdom of the FDA, (IMHO, the most corrupt part of our government more on that later) a part of the bioequivalency laws basically say that the amount of active ingredients in generics can vary by 20%! Now the amount of drugs is not always the only measure of efficacy, granted, but if my doctor has prescribed 37.5 mg of anything, and the label reads that it contains 37.5 of that drug, there better, by god, be 37.5 mg of it in there. But guess what? there aint!
The only way to really find out the actual amount is to find a well-camoflaged document on the companies’ website that details the amount in the most obfuscative language possible. If ANY other industry in the world did this, you can bet they’d be brought up on charges of fraud immediately, and rightfully so. If PepsiCo gave you 11 fluid ounces of soda, everyone’d be out of their mind with irritation, but if Merck or GSW does it, its OK?

In nearly every type of generic that ive seen, and granted thats not very many, not a single one has contained the full amount of prescribed med. Only 80%.
The difference is made of binders, fillers and whatnot. THe reason that they can get away with this, is that the qualifiers for efficacy ( bioequivalency ) are so narrowly limited that even variations of 20% dont affect the stats. This is the pharmaceutical equivalent of giving the kid who finished last, a ribbon for showing up with no regard for the winner. So, for example, how quickly the med is absorbed into the bloodstream as someone above cited, is a qualifier that is not affected by the variation in volume. Does this sound like a rigged game to you? sure does to me.

The point is this: the pharma lobby has introduced so much crap legislation into the business of drugs, that the very department whose mandate is to protect the american public from the drug companies, has become their greatest ally. This statement can be borne out by several examples of chicanery. Who do you think it was who asked the FDA to offer a speeded up approval process, costing much, much more? Heres a hint, it wasnt the FDA, but the new process sure got implemented quickly.

To wit: If you, joe average, somehow come up with a cure for something, and dont have enough money ( as determined by the FDA ) you will not be awarded the patent. Granted, its more complex than this, but thats the upshot. Even if you can afford the costs associated with the drug trials which range in the millions of dollars.This position was even documented in a letter from the FDA to Dr. Bryzinski, a well-known and hotly debated cancer researcher with sometimes amazing and sometimes dubious results. (With regards to him, i really cant say either way, but I do know the FDA has lost nearly every time when theyve attempted to attack the guy legally, even though they approved his drugs for use, then later attacked him for doing so.)

The FDAs patronage has long been for sale, especially to members of our own government with an axe to grind. In 1989, L-Tryptophan was taken off the market due to an estimated 5000 cases of (EMS) eosinophilia-myalgia syndrome. This outbreak was not due to the L-Tryptophan in an of itself, but an impurity found exclusively from one japanese manufacturer. This restriction was never lifted despite L-Tryptophan never being re-classed. You can buy it, but its pretty darn tough to find as manufacturers who are not drug companies cannot or wont afford to litigate. Finally on the topic of pot, despite NOT ONE SINGLE DEATH being directly attributable to marijuana, it remains on a list of controlled substances.
Does this have anything to do with health in the least? Nope.

Im not a doctor or a medical expert, Ill grant you, but I know snakes when i see them. Also for what it’s worth, there’s plenty of things ive been wrong about before, and may be here too. If theres something Im wrong about, tell me why. Otherwise lets get some pitchforks and torches!

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Stanislaw Bryzinski? You mean this guy?

Color me unimpressed.