Generic drugs. Rant

[Malcolm McLeod]

Just to throw in a third leg for this 'stool' (and for a touch of irony), I recall reading that people are occasionally cured by the placebo in clinical trials.

[Mike Hollingsworth]

Generic Viagra is going to be a Planet Changer.

[Greg Peterson]

Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.

Makes perfect sense.



Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.

Plenty of wiggle room in this specification. Same amount of active ingredient is easy enough to do.


Treat the same medical condition.

Again, this is pretty straight forward.



Be absorbed into the bloodstream at a similar rate and over the same period of time.

Here is where the divergence starts. By similar, I take that to mean the release rate and absorption rate do not have to be identical. Strength, dosage form and route of administration must be identical, but the rate by which the active ingredient is released and absorbed is allowed to vary by as much as 45% as that of the name brand.


Meet the same requirements for identity, strength, purity and quality.

Easy enough.

Be manufactured under the same strict standards that FDA demands of brand-name drugs.

Depends on who is monitoring quality control.

All the ingredients in the name brand drug are there for a reason and their interaction with the delivery of the active ingredient is not documented for the generic market. Like most other clones or copy cat items, generics are by practice and definition not the same as the name brand that went through extensive research and development. Perhaps for a vast majority of applications the allowable variance in generics are not a problem. But it appears there are some medical professionals who have discovered and documented their findings and submitted them to peer reviews. Even this extensive counter to industry claims will not be enough to sway some opinions, but at some point the facts must mean something.

[Mike Null]

Count me among those who strongly advocate generics. I take three and I remember the terrible prices I had to pay for the branded versions. I've been taking these drugs for nearly 20 years. I'll be 80 in a couple of months so I guess the generics are working.

[Greg Peterson]

Count me among those who strongly advocate generics. I take three and I remember the terrible prices I had to pay for the branded versions. I've been taking these drugs for nearly 20 years. I'll be 80 in a couple of months so I guess the generics are working.

I don't think anyone is discounting the value generics bring to the market. The discussion has morphed into whether or not generics are identical to the name brand. Some say they are and question the motives of doctors and scientists. I say they are not identical because the production, the recipe if you will, is proprietary.

You can get the ingredients right but the magic happens in factory.

[Mike Henderson]

I don't think anyone is discounting the value generics bring to the market. The discussion has morphed into whether or not generics are identical to the name brand. Some say they are and question the motives of doctors and scientists. I say they are not identical because the production, the recipe if you will, is proprietary.

You can get the ingredients right but the magic happens in factory.

I've heard stories of people who had trouble with a generic drug but no problems with the brand name.

It's really simple. If the generic doesn't work for you and the brand name does, go for the brand name. It may cost you more, however.

If the generic works for you, take the generic.

All the arguments about whether the generic is exactly the same as the brand name are meaningless. The only thing that matters is which one works for the individual.

Mike

[We know that many, many people take generics and are helped by them.]

[Michael Weber]

I'm the OP. i did not intend to imply all or even many generics were untrustworthy. Just that there is a possibility for abuse by unethical actors. I'm sure the FDA does all it can with the resources available. Those resources are not adequate when applied to control in foreign countries. The fact the FDA says this or that on its web pages doesn't really inspire my confidence. There is a trust issue here and most makers are aware that a loss of trust would be a bad thing for their businesses. I am heartened by the independent confirmation by university research facilities. I'm confident that most generics will be deemed okay and any failures will be rectified. As the saying goes, trust but verify.