coolycat wrote:....Also, did you see that the second person with PML, has NOT died? That story was retracted.
flora68 wrote:coolycat, if you're still around...
I know a lot of other people feel the same way you do about Tysabri looking so promising, and then being taken away as suddenly as it was released. Angry, frustrated, despondent, suspicious, in denial, whatever; there are a lot of bad feelings. Regardless, they're your feelings and you're entitled to them.
But you're venting them in the wrong direction, kid. Harry didn't do anything to anybody, nor did Deb. They just figured it out before you did, that's all .
However, you are right about one thing ; most people in the trials did report significant improvement on Tysabri, as did many who started on it after FDA approval. No doubt about that part. And it's also true that "only" 2 people in the trials died from it so far, out of almost 3,000.
And to someone who obviously knows (and cares) little or nothing about things like scientific method, drug trial protocols, the immune system, and the many other decidedly un-sexy facts and details of this situation like JCV and PML, those figures may sound like acceptable odds. Sounds like "only" 2 people died, out of almost 3,000 "helped", right?
Because they weren't finished yet! (Speaking of which, why, precisely, do you "find it unlikely" that there would have been any more deaths if they hadn't suspended use of Tysabri?)
You can't tell how further Tysabri use would have worked out any more than you can tell by the number of characters alive at Intermission how many will still be on their feet by the end of the last act.
More importantly, no medication can be considered a success if the patients start dying off after only two years of trials.....
There's no reason to assume that the improvement seen with Tysabri would or wouldn't have continued indefinitely, particularly without harm to the patient. I can tell you that leaving one's brain totally defenseless against things like meningitis or encephalitis isn't going to remain anyone's answer for long.
No, coolycat, people with immune systems don't just up and die from the JCVirus.
And there are important reasons why drug trials are supposed to last longer than Tsaybri's did before unleashing it upon the masses, no matter how impatient people are to cut to the punch line.
A bit of advice: If you're really hoping to hold your own in this particular "discussion" with two MS-research heavyweights like Harry and Deb as opponents, do yourself a favor and actually do some reading first. The last article pasted would be a good place to start.
flora68 wrote:coolycat wrote:....Also, did you see that the second person with PML, has NOT died? That story was retracted.
What specifically is your source for this information?
Below is my source for info on the 2nd death.
coolycat wrote:....Please look back at my original post, I was not venting. My goodness, I didn't realize how personal some folks take things here.
BTW, there have not been 2 deaths.....there has been one.
It's statements like that, that upset me.
Also, Harry didn't "figure" it out. He was merely repeating what he was told from an inaccurate source.
AND I would never classify he or Deb as a heavyweight when it comes to medical research.
I do not appreciate being talked down to.
My goodness, I didn't realize how personal some folks take things here.
OK, I'd like to stop this grade school bickering here.
BTW, saying that Tysabri was fast tracked could have prevented these problems, did you stop to think that these people still would have contracted PML? Do you think that clinical trials should be stopped indefinitely? I mean after all, that's the only way to prevent anything like this from happening, correct?
The way I see it, this is the only way we will ever make advances in medicine. It's a shame that people die, I know this, but something has to be done for the greater good.
They did voluntarily suspend it. Correct? AND the final say so was left up to the FDA.
Also, did you see that the second person with PML, has NOT died? That story was retracted.
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