Well, cars certainly kill more people every day than Vioxx and Celebrex
together ever will. The Vioxx story is pretty sad, and it's highlighting
a number of things that are wrong with the current system of drug
approval that should be fixed ASAP.

However, the press and interested lawyers have made it sound like taking
Vioxx was sure to kill you. Nothing could be further from the truth. It
increased relative risk from a small number to a bigger yet still small
number in a trial of people with arthritis (who often have an elevated
risk of heart attacks anyway) that used a relatively high dose
continuously for 18 months. But now every heart attack is Vioxx's fault,
and Merck likely will lose billions of dollars in lawsuits. And people
wonder about high drug prices...

Thomas

From ClinicalTrials.gov:

   Study Phase
   Most clinical trials are designated as phase I, II, or III, based
on the type of questions that study is seeking to answer:

       * In Phase I clinical trials, researchers test a new drug or
treatment in a small group of people (20-80) for the first time to
evaluate its safety, determine a safe dosage range, and identify side
effects.
       * In Phase II clinical trials, the study drug or treatment is
given to a larger group of people (100-300) to see if it is effective
and to further evaluate its safety.
       * In Phase III studies, the study drug or treatment is given
to large groups of people (1,000-3,000) to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the drug or treatment to be used
safely.

   These phases are defined by the Food and Drug Administration in
the Code of Federal Regulations.

   Click the check box to the left of each study phase that you wish
to include in your search. Select one or more study phases. If you do
not select a specific phase, trials in any phase that match your other
search terms will be retrieved.

On the bright side, there might be a  chance you could get in on the Phase 3
study (which may mean you only need wait a  year or two from now).

I wonder how in the heck they find these volunteers. How can these people
possibly be induced to participate in a phase 1 trial. That sounds so scary.
These people are supposed to be folks in fairly good health. Over the years
there must have been a number of them who suffered unpleasant side effects
from these drugs, and I'll bet some of them died also. I seem to remember
seeing adverts asking for volunteers in some newspapers. It wouldn't
surprise me if some of them are hard up college students trying to
supplement their income while in school. I'm sure that some of the drugs
they try are fairly harmless, then there are those other drugs like
interferon or ribavirin. I am having a difficult time myself in dealing with
some of the sides, but I'm trying to extend my life for a little longer. I
feel for those who participated in the trials and suffered. I wonder if some
of them are convicted prisoners trying to reduce their sentences. One thing
I experience is a loss of  emotional stability. I mean, I tried to watch a
program earlier tonight about folks who survived the recent tsunami, and
found I had to change the channel, because I could not contain my tears.
There are times when there is nothing going on crisiswise, and I start
crying for no reason. I know this is a side effect, but it is alarming all
the same. Thomas, you bring a wealth of information to the table, and I for
one am glad you share this with us. Thanks.
John

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