5 ms·

Generics might be cheap knockoffs. It's uncertain if the purity, formulation, method of production, and quality control for a generic will yield the same benef

Generics might be cheap knockoffs. It's uncertain if the purity, formulation, method of production, and quality control for a generic will yield the same benefits (or any benefits) for a particular drug. There are countless stories about how some people like some brands of generics better than others. There was some reporting around these parts recently that generics don't really undergo any kind of efficacy studies, they are assumed to just work, and there's really not much oversight whatsoever.

Iv 7y ago
Hmmm, I must confess I don't know the specifics of the laws and controls, but box of medicine have to state the composition: the molecules present and their quantities. Got prescribed 3 mg of TradeMarked(tm) <moleculeXXX>, a generic would be 3mg of NoName <moleculeXXX>. I think labeling a generic incorrectly would result in pretty heavy fines.
- linuxftw 7y ago
  Consider magnesium supplements. You can get magnesium in a variety of forms: magnesium oxide, magnesium citrate, magnesium taurate, magnesium glycinate. Each one of those formulas is going to contain magnesium, but the magnesium is bound to another molecule. One form of magnesium maybe be more effective than another for any given individual or condition. Some products are labeled as just "Magnesium" and it's unclear what form the magnesium is in. Then there's a consideration of yield and purity. If you're making a compound through a given process, it's going to yield X amount of the desired compound, and Y amount of something else (other compounds or unconverted materials). Some of this is going to make it into the end product. If two companies are using totally different processes to create the same end compound, everything is going to be different. > I think labeling a generic incorrectly would result in pretty heavy fines. Who's watching? I don't recall hearing much about generic manufacturers of prescription medications facing much scrutiny.
derefr 7y ago
It’s kind of weird. The FDA, and agencies in other countries modelled after it, usually have two jobs: • for drugs, such agencies verify that new drugs are safe/effective in concept (rather than in any particular manufacturing implementation) • for food, the agency looks at specific manufacturers and distributors of a food, and—given a particular food they’re claiming to be producing—the agency verifies that their product meets the agency’s own definition of what that named food “should” be (i.e. you can’t sell Cheez Whiz as “cheese” because it doesn’t contain enough [whatever], though you can sell it if you don’t try to call it “cheese”; you can’t sell beef as “beef” if it contains toxic levels of thyroid hormones, though you could sell it as something else, e.g. as a hypothyroidism supplement, since those levels would be expected for that product; etc.) But, strangely, these agencies don’t have any mandate to to apply the “food”-type rules (checking manufacturers and distributors for their output being within tolerances to a definition) to the drugs—even when those drugs are known to be produced through a process that can leave harmful reagents in them if not cleaned properly. What’s up with that?
- linuxftw 7y ago
  > What’s up with that? I suspect it's all about who benefits. In the food industry, we've seen the effects, the industry is consolidating and forcing smaller players out. In the case of generic prescription drugs, those are still very large players. There seems to be a cartel for all but the most common drugs, where manufacturers don't bother competing for market share.

Iv 7y ago

Hmmm, I must confess I don't know the specifics of the laws and controls, but box of medicine have to state the composition: the molecules present and their quantities. Got prescribed 3 mg of TradeMarked(tm) <moleculeXXX>, a generic would be 3mg of NoName <moleculeXXX>. I think labeling a generic incorrectly would result in pretty heavy fines.

linuxftw 7y ago
Consider magnesium supplements. You can get magnesium in a variety of forms: magnesium oxide, magnesium citrate, magnesium taurate, magnesium glycinate. Each one of those formulas is going to contain magnesium, but the magnesium is bound to another molecule. One form of magnesium maybe be more effective than another for any given individual or condition. Some products are labeled as just "Magnesium" and it's unclear what form the magnesium is in. Then there's a consideration of yield and purity. If you're making a compound through a given process, it's going to yield X amount of the desired compound, and Y amount of something else (other compounds or unconverted materials). Some of this is going to make it into the end product. If two companies are using totally different processes to create the same end compound, everything is going to be different. > I think labeling a generic incorrectly would result in pretty heavy fines. Who's watching? I don't recall hearing much about generic manufacturers of prescription medications facing much scrutiny.

derefr 7y ago

It’s kind of weird. The FDA, and agencies in other countries modelled after it, usually have two jobs: • for drugs, such agencies verify that new drugs are safe/effective in concept (rather than in any particular manufacturing implementation) • for food, the agency looks at specific manufacturers and distributors of a food, and—given a particular food they’re claiming to be producing—the agency verifies that their product meets the agency’s own definition of what that named food “should” be (i.e. you can’t sell Cheez Whiz as “cheese” because it doesn’t contain enough [whatever], though you can sell it if you don’t try to call it “cheese”; you can’t sell beef as “beef” if it contains toxic levels of thyroid hormones, though you could sell it as something else, e.g. as a hypothyroidism supplement, since those levels would be expected for that product; etc.) But, strangely, these agencies don’t have any mandate to to apply the “food”-type rules (checking manufacturers and distributors for their output being within tolerances to a definition) to the drugs—even when those drugs are known to be produced through a process that can leave harmful reagents in them if not cleaned properly. What’s up with that?

linuxftw 7y ago
> What’s up with that? I suspect it's all about who benefits. In the food industry, we've seen the effects, the industry is consolidating and forcing smaller players out. In the case of generic prescription drugs, those are still very large players. There seems to be a cartel for all but the most common drugs, where manufacturers don't bother competing for market share.