No Tysabri, but plenty of the abortion pill

amelia

Let me rant a little. Now I don't want people to die and I do want the best outcome of Tysabri, BUT this week, the FDA finds that Ritalin, probably misspelled, may cause an increase in cancer, but they will have to do a long term study, while still given to many children everyday. The abortion pill kills mothers and obviously kills babies, and now they are wanting to put it OVER THE COUNTER! They have even proved that the DR's data and comments on helping it to get approved were VERY biased. Now the whole Tysabri thing has, so far, only been with those on Avonex. I just don't know about all of this. I know Biogen pulled Tysabri, not the FDA, but are we seeing a trend of stupidity here? Thanks, I needed to just get that off my chest!

OddDuck · Posted: Fri Mar 04, 2005 2:48 pm Post subject:

Hi, amelia.

I totally understand your frustration.

All I can say is the common denominator and bottom line of all of what you mentioned is simply "disclosure". If (or you could say "since") at the very least, all of the side-effects, etc. and/or even mechanisms of action have been FULLY disclosed (no matter what the MOAs actually are, such as the abortion pill), these drugs will be allowed to stay on the market.

The problem with Tysabri was just that. It is highly suspected that any possible problems were NOT fully disclosed up front. Had Biogen and/or the FDA simply just fully and honesty disclosed the possible risks and/or safety concerns (as I tried to alert the FDA to do), patients would have been making a more fully informed decision about taking Tysabri (which is the law in medicine - i.e. "informed consent"), and Tysabri would never have had to be taken off the market at all. It doesn't matter how "horrible" the possibilities or possible consequences of taking any drug might be, it all just boils down to disclosing those possiblities up front BEFORE putting it on the market, and putting those precautions, warnings and contraindications in writing and made available to physicians and patients alike BEFORE taking or distributing the drug.

That's what the whole Tysabri thing rests on, basically (aside from the possible SEC charges, but that's a different aspect altogether).

When the label came out, I cringed. All they would have had to do was to disclose more and put better warnings in the label and all this most likely would have been avoided.

That was all that happened with Merck regarding Vioxx. They simply didn't do proper "disclosure".

It's a shame, I agree.

Deb

JFH

amelia · Posted: Sat Mar 05, 2005 11:06 am Post subject:

Let me rephrase myself, as I know everyone has their own opinions. The pill has killed some of the women that have taken it, mothers, and it does dispose of embryos. Sorry if I offended anyone, I did not intend to.

texas_jim · Posted: Sat Mar 19, 2005 11:31 am Post subject: wrong forum

this is not really the place to discuss abortion, roe v. wade, etc except maybe in the context of fetal stem cells.

andrepol