Topics Related to  Prescription Drugs, Anxiety, and       

       Depression

Generic Drugs versus Brand-Name Drugs: Are They Equivalent?

This is a topic that is fascinating because both points of view, namely, the equivalence or non-equivalence, of generic drugs to the original brand-name drugs can be argued convincingly.

First, let's argue for the equivalence-which I'll make very brief because you can find many lengthy, well written and reasoned tomes on the subject.  Basically, the argument centers around the FDA approval of generics: the FDA requires  purity testing of generics, as it does of brand, and further, there must be bioequivalence, that is, when healthy humans are dosed with the generic, the blood drug levels must be be about the same as if the same amount of brand was dosed.  So the argument is that you can then call the brand and generic "equivalent"-or, to put it a different way, "equivalent" is defined by the  ex vivo testing.

Here are my objections to the standard reasoning which appears summarized above:

The generic drug that is dosed is not identical, it is at best "equivalent" chemically.  What is very seldom mentioned is that the generic manufacturer cannot use the same process to synthesize the active drug as the original brand manufacturer used.  In fact, it is common practice for brand manufacturers to purchase generic drug and then analyze it for impurities-if the impurity profiles of the generic and brand are very similar, it is powerful evidence that the generic manufacturer used the same process to produce the drug, which they are forbidden to do.  So generic drugs are expected to have a different impurity profile than the original drug that was tested extensively in humans.  Is that ever a problem, considering the impurity levels for all drug substances are required to be so low?  I worked on a drug once in which (unbeknownst to all of us) all of the drug's therapeutic activity was due to one of its impurities-as was all of its toxicity.  So it can matter.

The only difference-for example for a tablet-between the brand and the generic, in terms of formulation, is the stuff the active drug is mixed with (the excipients)-things like starch, talc, artificial colors, etc.  But there is a significant assumption made here, namely, that the excipients don't affect the therapeutic effect; which is a scientifically good argument.  But let us look at our own experience: visit your local grocery or drug store and look at the dozens and dozens of formulations of aspirin or ibuprofen, for example.  The cheapest aspirin in the store is just generic aspirin, no fancy logos, no "extra fast acting!" labels.  But all those dozens of different formulations of aspirin are doing a thriving business-why?-because you believe that Bufferin works better for you and I believe Excedrin works better for me.  If formulation makes no difference, why aren't we all buying the cheapest aspirin in the store?  Because we feel our brand of aspirin works better than the store brand and so do the majority of people that purchase aspirin products. So maybe the way a drug is formulated does make a difference in therapeutic effect, at least sometimes. The same argument could be made for alcohol-containing beverages-if you drink an equivalent amount of alcohol in the form of vodka, beer, wine, scotch, a Manhattan...do they all affect you the same way?-they all supply the same amount of "active ingredient".  Beyond our own subjective assessment that different formulations affect us differently, there are clinical studies with some generic drugs that show nonequivalence of some generic and brand drugs .

But then there is bioequivalence.  That means the generic drug must give the same serum (blood) drug levels as the brand (as an interesting side note, in one infamous case, a generic drug maker couldn't get their generic drug to pass bioequivalence, so they they illegally swapped their generic for some brand material they had purchased. Surprise! The material then passed bioequivalence).  Well, what does that mean in terms of data?  The real problem is that the range of blood levels for the ingestion of the same amount of drug varies greatly from individual to individual-in one study on serum levels of Prozac, the variation was plus or minus 40%, which is not at all unusual.  The generic has to come within that range to be "bioequivalent".  Let's put that in terms we can understand better: if you make $100,000 a year and I make $60,000 a year, is it O.K. to say our incomes are "equivalent"?  (not to belabor the point, but part of the problem of comparing serum drug concentrations is the measurement process itself-it is difficult to determine accurate and precise drug-in-blood concentrations).

Part of the implication of "equivalence" is that generic drugs are manufactured in the USA. The largest manufacturer of generic drugs is India.

You aren't paying for the medication you bought, you are paying for the drugs that didn't work. Hunh?  O.K., that statement is only 99% true.  Most medications-let's say tablets, cost a few pennies at most to produce; in some cases, the plastic container and the label cost more than the medication you paid $150 for at the drug store. Wow, doesn't that make you angry?-those darn pharmaceutical companies making tablets for pennies and charging you a week's minimum wage?  Not so fast.  Pharmaceutical research is like wildcat oil-drill a hole here, get all excited, finally give up, drill a hole over there, etc.  Every one of those "holes", or drug candidates in our discussion, costs tens or hundreds of millions of dollar to "drill".  A funny aside is that pharmaceutical companies usually swear by all that is sacred that they will drop development of a drug (and therefore, save both you and the company money)  the second it is certain that the drug won't be able to be taken to market, often because of unforeseen toxicity. But remember all that enthusiasm that I wrote about that is generated when the drug is first discovered and it seemed like the drug will be, to use the industry jargon, "first in its class"?  Stopping all those scientists and project managers from trying to progress the drug is like stopping a freight train (a freight train takes about a mile to stop once the brakes are applied, just so you  picture the situation  a little more vividly). 

There are many, many failed drugs, each costing tens to hundreds of millions of dollars to investigate, only to find they weren't suitable for FDA approval.  When you buy that $150 bottle of medication, that's a lot of what you are paying for-failed drugs...but no one has ever found a better way to make the marketable drug  hunt more efficient and less expensive.  Drug discovery is literally a hit-or-miss, very expensive proposition-and that's what, in part, makes medication expensive.

But for the generics drug maker, the only cost is the cost of making the tablets and that is why they are so inexpensive.  Many chains (Wal-Mart, Target, Shop Rite, Stop and Shop) offer 90-180 generic tablets for about $10-that's about a dime or less per tablet, and they are making a profit.  For the generic manufacturer, making tablets at the lowest possible price is the name of the game.

But what if something goes wrong with a batch of medication that is put on the market?  If it is a brand medication, the headline will read, "Johnson & Johnson withdraws drug X from the market because of poor quality control".  You'll think about that next time you think of buying a J&J product. But what if a generic drug is withdrawn from the market?  Then the headline is "Pleebar Pharma, LLC withdraws drug X from the market because of poor quality control".  Are you going to remember that?  Quick, name three pharmaceutical companies-and now, name three generics manufacturers (Mylan, Teva, Watson).  Brand name drug manufacturers have a visible (and memorable) name to protect that generic drug manufacturers do not. 

To put a fine point on it: do you remember what drug was contaminated with cyanide and taken off the market many years ago?  Tylenol, right.  That was 28 years ago-and you remembered-the point being, again, if you are a household brand, you don't want bad publicity (incidentally, it wasn't drug adulteration by the company, it was a much more interesting story).  Do you recall the generics manufacturer that had several executives indicted for falsifying test results in seeking FDA approval of several medications?  Now that is a HUGE deal, you must remember that! Hummm...

The final point to think about is that most human of instincts: greed.  If you buy a brand name prescription drug, the pharmacist doesn't make a lot of money; if you buy a generic, he/she will make a lot more.  No matter how scrupulous the morals of the pharmacist, it is not difficult to see how this disparity in profit clouds the "are generics equivalent?" argument (this argument is not valid, of course, for the "buy three months worth of some generic drugs for about $10" programs).

With all the above objections, most generics are probably suitable in most cases-but to be on the safe side, it might be prudent to fill your first prescription with brand drug (ouch!  it cost a lot, I know-but would you rather save money and buy something that didn't work?).  If that drug works out for you-no matter if it is an antidepressant, antihypertensive, etc., great.  Switch to the generic if that's economically mandated (or health insurance company mandated) and see what happens...if the drug continues to work well, note the generic manufacturer (it won't be any company that is a household word, in all probability) and ask your pharmacist to refill in the future with that generic company's product.  And if the drug stops working at some point, be suspicious of whether it is your body's biochemistry changing or it is the generic drug lot.  A Founding Father is sometimes quoted as saying, "the price of Freedom is constant vigilance".  Perhaps the lower price of generics is also constant vigilance.

For a partial listing of sources of those aforementioned inexpensive generic medications, see:

http://www.hughes13.com/new_page_4.htm

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