While driving home today, I heard a comment from a candidate for an office in Arizona. She was a physicist. While talking about how Obamacare was wrong for the country she brought up as support that we were all being forced to use generic drugs and sometimes they work, but sometimes they don't work as well as the name brands. With all of things that are wrong with Obamacare, generic drugs are not one of them (mandating generic drugs is, but mandating name brand drugs would be just as wrong, as is mandating coverage of pre-existing conditions).
First off, my guess is the physicist doesn't understand something about generic drugs. This can be excused. I'll take peanut butter as an example. If you go to Walmart, they sell the brand of peanut butter that God eats, Skippy. They also sell, Peter Pan and their own no-name brand. Or generic peanut butter. Generic peanut butter is not the same thing as Skippy. They are chemically different. The ingredients (and proportions of ingredients) are different. This is because Skippy's special recipe is protected by trade secret (which means the company doesn't tell anyone). Coca Cola, Kentucky Fried Chicken, Pepsi, Dr. Pepper, and McDonald's Special Sauce are likewise protected as trade secrets.
Trade secrets are good, if your company is able to keep it a secret. No one can breach a trade secret. Not because the courts will prevent them (on the contrary, the courts have no jurisdiction over mere trade secrets), but because the companies jealously guard the secret. I have heard (but can't confirm because I am not one of them) that there are only two executives at Coca Cola that know the entire formula and they are not allowed to be in the same location together. The KFC recipe of 11 herbs and spices is mixed at separate facilities and then combined at a third. A trade secret gives the company a monopoly on their corner of the world as long as the secret remains a secret.
Drugs on the other hand are not protected by trade secrets. Not a single one of them (at least not any that are anywhere close to coming to market). Drugs are patented early on in the process and as part of it, their chemical makeup is divulged. They are then tested, retested, retested, and retested before being blessed by the FDA. It is really a race against time from when the drug is patented to when it is finally approved and marketed to have enough time left on the exclusivity of the patent to make back the investment. The patent process protects the invention (in this case a drug) so that the owner of the patent has exclusive rights to make or sell license to make that particular drug.
Once the patent time runs out, it is fair game for anyone. Companies that make generic drugs don't waste valuable dollars on R&D, they make tried and true formulas which they get for free from the patent office. The drug they make is approved by the FDA because IT IS THE EXACT SAME AS THE ORIGINAL. OK, that is not true. Company A stamps their pill "R-87" while Company B stamps their pill "5N0P". The active ingredients are the same, the inactive ingredients are the same, the dose is the same (and usually the size and shape are the same - unless that is protected by a different patent).
So Skippy peanut butter tastes better than generic peanut butter because it different. Equate Acetiminephin works identical to Tylenol because they are the same thing. Whats more, in some cases the generic brands are made by subsidiaries of the name brand companies. Furthermore, in a lot of cases the generic companies will sell their drugs to everyone. So not only is Walmart Tylenol the same as K-mart Tylenol and Kroger's Tylenol and Walgreen's Tylenol, more than likely they came off the same assembly line and just were detoured to a different labeling machine.
So to say that generic drugs sometimes work and sometimes don't work as well as name brands is patently false. If the generic doesn't work one of two things is happening: 1) the name brand doesn't work either or 2) you have a psychological response that is inhibiting the drug (sort of a reverse placebo effect). In case #2, this is an expensive problem that you should be able to solve with a little positive thinking and getting rid of your irrational fears.
One of the things you don't mention is the allowable variance of strength allowed for generics. Generics are allowed a 10% variation from the stated dosage of the name brand. This can cause significantly different results in the patient due to the higher or lower dosage then the name brand. Adding to that is the patient might not get the same generic brand each time they fill a prescription causing more problems.
ReplyDeleteExcept that the bioavailability or bioequivalence standard (the variation you are talking about which I believe is actually up to 20%) applies to the name brand manufacturers as well. Example: Name Brand Company creates a drug with active ingredient A at a dose of 10 mg. They are allowed to manufacture it with a dose of 8 mg to 12 mg and still call it 10 mg (so long as their studies have shown that the 8 mg and 12 mg have no statistical difference in the effects). Once it goes generic, the generic companies can do the same thing. The Name Brand is not held to a higher standard, they just spend all of the research dollars to show that 8mg and 12mg are pharmacologically identical to 10mg. Otherwise cost of manufacture would be prohibitable expensive to ensure that you ALWAYS have exactly 10 mg.
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