One of Them Self-Hatin' Smokers!

[Hauptman]

Effectiveness is looked at somewhat in Phase II and most of Phase III trials are primarily concerned with efficacy. Most crucial safety data can be obtained with an extended Phase II study. Phase III studies are usually 30-50 times larger then Phase II studies and can cost anywhere from 10-50 million dollars. So, I stand by my statement that most of the money is spent on proving efficacy.


Let's say that Toyota can show that it can make the most efficient, cheapest cars. Does that mean that unless Ford proves that it's cars are as efficient, cheap, pretty, etc... then the government has a right to tell it "We already have a car on the market so we don't need another car." As far as whether or not we allow snakeoil salesmen a free ride or not, have you ever seen a commmercial for Enzyte? Yes, we already do that. So why are drugs and different from natural supplemements? My doctor gets a lot of money every time I go to his office. If he's prescribing me something I expect him to know if what he's prescribing me works or not. And I expect the pharmaceutical companies to convince my doctor that what they want him to prescribe me will work. I just don't see why the government needs to interfere in that part. Should the government be concerned with Safety? Absolutely. Efficacy? NO



I'm not suggesting that we need to get rid of the FDA. And I never said that. I'm saying the FDA should focus all it's resources on making sure the drugs we get are safe. Let the market take care of everything else.

I can't dispute your dollar amounts regarding the research, but then I do know that the pharmaceutical companies spend far more on advertising than they do on research. And considering that while the drugs are still under patent protection the companies charge pretty much whatever they like because they know they have a captive audience.

But more to the point, the FDA isn't as concerned with the amount of efficacy so much as the honesty of the claimed efficacy. To use your car analogy, until recently the gov't didn't care how fuel efficient the cars were, but how honest the claims of fuel efficiency were.

On the other hand, since the gov't is the single largest purchaser of drugs through Medicaid, Medicare, etc., there is an incentive for them to have accurate numbers regarding efficacy.

Finally, a car is intended to get a person from point A to point B, and the gov't has an interest in safety because waiting for market forces to deal with safety could cause many thousands of deaths before those market forces can make a difference.

In the case of pharmaceuticals, lives are obviously also at stake, but as I stated before it's not just the safety of the drug being used but the danger of opportunity cost. If there are two drugs to deal with my illness and I choose the wrong one then I might die even if the drug I took is essentially "safe". Thousands of people can (and have) died from relying on the pharmaceutical companies and market forces to deal with it.

[treehugginfencer]

It's not Obama's fault if he still smokes, it's the fault of those heartless tobacco corporations who hooked him! Can't you see that the only way to stop this madness is to put them out of business?

[erik_blank]

It's not Obama's fault if he still smokes, it's the fault of those heartless tobacco corporations who hooked him! Can't you see that the only way to stop this madness is to put them out of business?

Troll, Troll,Troll,Troll... Doobe doobe!
Troll, Troll,Troll,Troll... Doobe doobe!
Troll, Troll,Troll,Troll! ... Wooo Wooo Wa woooooooooooo!!!!

[I_luv_saber]