Re: FDA, User Fees, Adverse Effects, and Safety

From: Jeff (kidsdoc2000_at_hotmail.com)
Date: 03/28/05

  • Next message: Sharon Hope: "How Lipitor got FDA Approval - book ''Inside the FDA,"" 
    Date: Mon, 28 Mar 2005 02:16:17 GMT

    "Sharon Hope" <shope@anet.net> wrote in message
    news:i7idnVwvZqGvQtvfRVn-vA@comcast.com...
    >
    > "Jeff" <kidsdoc2000@hotmail.com> wrote in message
    > news:gPp1e.6384$z.4061@newsread2.news.atl.earthlink.net...
    >>
    >> "Sharon Hope" <shope@anet.net> wrote in message
    >> news:ud6dnctLdZzWRNjfRVn-2Q@comcast.com...
    >>
    >> (...)
    >>
    >>> Prozac also has dangerous adverse effects, and the adverse effects of
    >>> this last school shooting illustrates clearly that people who are not
    >>> patients are also at risk from adverse effects. Label-reading warnings
    >>> about suicidal thoughts and violence on purchase did not enter into the
    >>> options of most of those who died or were harmed, or even just
    >>> terrorized - locally and remotely.
    >>
    >> Yet, we still don't know what really happened.
    >>
    >> It is premature to draw conclusions.
    >>
    >>> Drug safety is related to cardiology.
    >>
    >> So is careful understanding of the facts and careful thought about them.
    >> But we don't see them here.
    >>
    >>> Risk mitigation is more than adding fine print to a label.
    >>
    >> Yeah, it includes understanding the facts.
    >
    > How would you propose that we force the people who were murdered to
    > "understand the facts" about drug adverse effects? If you could roll back
    > the clock, would you force everyone in that school to sign that they
    > understand that a former student is taking a drug that might lead to their
    > own murder? Would that constitute "understanding the facts"? Absurd.

    Why not have the students and parents sign that they understand that not
    everyone in the school washes hands properly after using the toilet, and
    this spreads illness that could have the kids tossing their lunch?

    Why not have the students and parents sign that they understand that not
    everyone in the school is properly immunized and may spread disease?

    Why not have the students and parents sign that they understand that the
    kids who drive to school are not experienced drivers and are a risk?

    Life is a risk. It doesn't mean that we shouldn't do things to minimize
    risks.

    If I could roll back the clock, I would have the child better evaluated and
    other interventions taken.

    What I meant about understanding the facts, we should understand what
    happened to troubled young person. We don't, at least not yet. To blame a
    drug without understanding this is premature.

    Jeff

    >>
    >> Jeff
    >>
    >> (...)
    >>
    >
    >

  • Next message: Sharon Hope: "How Lipitor got FDA Approval - book ''Inside the FDA,""

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