However, just because everyone may know a guy who knows a guy who had a problem with a generic once doesn’t mean they don’t usually work, don’t save a ton of money, and the difference wasn’t just in the guy’s head.

I’m the first person to roll my eyes when, some guy goes nuts with a rifle and we find out he was/is on some new CNS drug - and then out of the woodwork come 40 people on this site claim they’ve now conclusively proved this CNS drug causes people to go nuts (wouldn’t someone likely to go nuts be on a CNS drug in the first place?). So just because we all know a guy who knows a guy doesn’t mean generics don’t work either.

If the formulation is so precise and difficult that a generic company can’t copy it then fine - they didn’t copy it, and they won’t be able to market it - and that’s a rare case. But if they did duplicate the drug’s PK, then it’s copied.

I have know several people that have been switched to a generic and they have eventually ended up back on the brand name when the generic didn’t work as well. One fellow told me he was having to more than double his dosage of the generic compared to what he was taking of the Brand name to control his illness. Not on his own mind you even the doctor said so. It was not more cost effective at that point.

BTW another thing is the Pharmacies make a lot more money on the margins/markup of a Generic over that of a brand name, so its in their best interest to switch to a generic if the precription doesn’t specify the brand name.

Generics have their place, just not for me!

The patents from which the generic is created by the generic manufacturer almost never come right out and say how these incipient, particle sizes and a myriad other properties are enabled in the final capsule or tablet is made. A considerable amount of technology goes into getting the active ingredient to be absorbed/dissolved in the digestive track. A lot of factors go into the formulation, most of which are not known or can be reversed engineered by a generic manufacturer. Even today with Dilantin off patent for probably 40+ years. No one makes a generic. Its only available as a brand name because no one other than Parke-Davis ever had been able to make a formulation of it that works. Its a Trade secret and people have been jailed for trying to steal it and sell it to other companies.

I have been involved in the past when I worked in the industry on drugs that although active as all get out failed because they couldn’t be formulated. Some we even milled to nanometer particle sizes to help them get dissolved to no avail. Usually ended up excreated before it was absorbed even through they where sub nanomolar active in solvents we could get it disolved in (none of which was human compatible!) I am sure plenty of other people from inside the industry would have similar stories to tell. Just because you have an active compound is only the start of the problem. As much research is done on formulation, dosage form and when to take the drug as creating the active ingredient.

I believe the studies are normally cross-over studies (brand to generic or vice-versa) and the analyzed parameters are Cmax and AUC. I assume it must be different with highly toxic drugs (oncology), or drugs that aren’t oral but I really don’t know how it differs.

No?

Of course, the empirical issue is how many individual clinical experiences add up to a real question, and what do the numbers really show. At this point, although not earlier, generics are presumed innocent by most providers.

I didn’t vote because, even now, I think we still need better data even for the “big picture.”

Even so, I just want to point one potential downside to generics by how pharmacies stock generic medications.

A generic is rated as bioequivalent if it delivers the active component of the drug within 80-125% of the brand name drug. When someone takes the brand name drug they always get a drug produced by the same company, and, presumably, always take an identical medication. When they go to generic they get switched to a new formulation from company X. For example, the new formulation might only delivers 80% as much drug as the brand, so the person gets 20% less drug. This may sound like a big difference, but most of the time this is normally not really a big deal. In the unlikely event it was a big deal, for example you’re no longer getting enough effect from your drug, the dose could be adjusted to compensate for this difference.

The thing is any given pharmacy doesn’t always buy the same generic - they just get the one their wholesaler carries - and the wholesaler almost always carries whatever one is cheapest at the time they ordered. So now someone goes back to the pharamacy to refill their prescription, quite satisfied with company X’s generic. But now the pharmacy dispenses a generic from company Y, since the wholesaler swtiched. This formulation delivers 125% of the active ingredient. Had the patient been on the brand, this would only deliver an extra 25% of the drug, but if the patient switched from company X’s generic (s)he increased the amount of drug he took by >50%.

Even so, this change usually doesn’t make much difference. I just point it out because it’s just one small speed bump you face when using generic drugs you don’t face with brand medication. However, from a society perspective, the cost savings compared to the minor and rare downsides of generic medication are enormous.