Short and direct! Re: Re: old vs new

[Guest guest]

 You have your Opinion, others have there’s and I have mine.

 

   It is a simple known fact there is RD before going to market and it is

also a very simple known fact that even after going to market other studies do

continue on medications! This is why some after they hit the market get pulled

or reformulated. This is what happened to Viox for example.

 Also a slight change in a med dose not always mean a delay of years before it

comes back to the market. The time span depends on what and how it was changed.

But they must be reproved by the FDA after any change another simple known fact.

 

    I also do not appreciate you’r trying to make it look as if I am stupid

and ignorant. Your statement “I believe that there is a lack of understanding

as to how things work in the pharmaceutical world†is both arrogant and

insulting! You insinuate that only you have any knowledge in this area.

 

    Now I will not have you dragging this on or insulting me here any more

period. If you wish to continue to act this way take it off line! the other

people here do not need it or want it!

Marty

 

________________________________

From: tracyminca

To: Stillsdisease

Sent: Sun, January 17, 2010 11:50:32 AM

Subject: Re: old vs new

Marty,

Although you are correct on many things, in this case, I believe that there is a

lack of understanding as to how things work in the pharmaceutical world. Laymen

often get chronological order confused with cause and effect. Just because the

medication made you sick doesn't mean that the reformulation was related to side

effects. In a perfect world, drug companies would respond to our complaints, but

that's not what happens in reality. Businesses do everything in order to make

money. Drug companies respond to side effects based on LIABILITY. And liability

equals lawsuits and loss of money.

Before a drug goes to market, it has been tested (R & D) in animal trials, then

clinical trials for YEARS. Therefore, if a drug has serious side effects show up

after FDA approval, either that drug gets pulled or a black box warning is added

(if the good it does outweighes the danger)..

No company can just pull a drug and tinker with it then put it back on the

shelf. Even the slightest modification requires more testing and FDA approval

again. That's because if you understand pharmacology, just a tiny modification

can be the difference between safety and death. To make a tiny modification, the

drug needs to go back to the beginning, get retested, get new FDA approval which

takes years.

When we see " new " formulations of drugs show up in our drugstores, those

formulations would have been in the R & D pipeline for YEARS. The most common

reason for a slight modification is NOT side effects, but upcoming PATENT LOSS.

If a drug company modifies a drug slightly, it extends their ability to have

sole rights to that drug and prevents generic versions from coming on the market

and stealing their market share of $$$. So when you see a " new and improved "

it's usually because the time limit on having the sole patent has expired so the

company puts out an " extended release " or something of that sort to extend their

patent and keep their market share. Money.

So just because a newer version appeared after your incident with the medication

does NOT mean that the reformulation had anything to do with what happened to

you. Yes, drug companies do take reports on serious side effects,

BUT.....changing the formula for a medication is a huge deal. If you tell me the

medication, I'm sure I can find information as to the reason for the change in

formulation.