Dangerously loosened FDA laws by Bush put us in jeapordy

Thanks for posting this.

You are quite welcome indeed, my old friend. I just want to let all my friends have a heads up that some stormy times might be
ahead. Especially with those 2 injectable medications to treat inflammatory
types of arthritis like rheumatoid, psoriatic etc. One name is Enbrel and I forget the other name. They are new. They are expensive.They can cause cancer. USUALLY the decision to use a certain drug is made based upon a balance between the benefits and the potential risks! That's one H*ll of a risk, and that is only one of them, the side effect profile is like looking at a list and saying to yourself: "This juice is definetely NOT worth the squeeze"

It's all Bush's fault. He probably owns those drug companies.

Now THAT'S a really scary thought !! Even if not OWNS, he was most assuredly very, very deeply in their debt and has now paid off.

Well, thing is, if no one ever tries a drug that's brand new, pharmaceutical companies will start losing lots of money. They put in 20 years worth of research, possibly $20 million on research and that's just for one single drug. During that time, they have their drug patented and it lasts only about 8 years after the drug is successfully released.

In those 8 years, the drug's sales has to make up for the money lost. They have to make their profit in those 8 years, before the other companies start making "Me too" drugs (their own version of the same drug).

They never state it, but the few years after the drug released is actually Stage IV of drug development. Doctors are given forms to fill in whenever a drug goes awry and they send those forms off to the companies.

FDA Laws must be made stricter, I agree. More animal testing, more clinical trials. However, even after all that done, the phamaceutical companies keep their eyes on the drugs after it is released.

The problem, of course, is that animal testing and even clinical tests will never pick up all the side-effects. So they have to prove that the majority of people will be safe and then release the drug, keeping an eye on the population for any side-effects they missed.

This all has to do with the fact that there one size does not fit all. Drugs work within a clincal window of safety. The larger the window, the better. Drugs might not work as well in you as in others, or work too well as compared to others. However, if you fall outside the window, well tough. You're the minority.

That's how drug companies work. Obviously, the companies don't want law suits on their hands, so they try to ensure the drug has a larger window of safety as possible. However, they can't always ensure it and that's because of the one-drug-fits-all approach. Tailoring a drug's reaction to every individual is financially impossible.

There will always be a risk with taking drugs, just as there will always be a risk with doing anything.

Still, FDA Laws should be tightened if they're not strict enough. We don't want another thalidomide incident do we (although really, to be fair, thalidomide couldn't have been predicted at the time).

You are preaching to the choir man. I'm a pharmacist & I know how much R & D gets put into coming up with a brand new drug. But they also make plenty of money off of the "look-alikes" w/a different name that only requires a short form of the FDA paperwork. FDA laws HAVE BEEN very, very strict ever since the experiences with that drug that caused a tremendous number of massively deformed infants being born. It was called THALIDOMIDE!! Claimed to be harmless and used all over Europe, then here in the USA, by PREGNANT women??? Their kids were born with no arms, no legs, it was just horrible the deformities that this
thalidomide caused. THIS is what resulted in the total strictness we have had in the past of the FDA and yes it DOES cause hardships on the drug companies, but most of them have all merged now so they have very little competition, and have TONS of assets. All they need is one hit in 10 or 15 years and they are once again SET FINANCIALLY FOR DECADES! NO - the people have the right to be able to sit down with their doctor and talk about ALL of the possible side effects of a drug before they start using it. The way Bush loosened up the strings, NO ONE KNOWS what the side effects are going to be. So how can a doctor and patient make any kind of informed decision? They can't - just like the mess with Vioxx and Celebrex. These patients did not know what they were risking and THAT is wrong. Every drug has side effects but we have the right to decide if WE WANT TO RISK those side effects or not. For moderate arthritis, that was an unacceptable risk, and that's why these lawsuits are going on. But the pharmaceutical industry has already made billions and billions over those drugs. No, I don't bemoan the drug research & development blues. That is just the business of research. Money gets spent and money gets lost. Look at Howard Hughes with his airplanes during WWII. Congress tried to fry him personally for all the government money he spent & then lost on airplane research. But he came to the Congressional hearings with a list of many billions of dollars more that had been spent on research for weapons, bombs, mines, tanks,you name it, everything....tons of which never came to fruition. The atom bomb did though didn't it? Now, that one sure made up for plenty of losses in terms of America getting the "spoils of war". We went to the summit meetings at the end of the war as the "MAN ON TOP" Nobody could touch us. No one dared. Nobody else could beat us. We WERE invincible. At least, until we began letting people
from ANY other country in the world come here to American universities where they could learn how to make atom bombs too.