Re: Editorial: patient choice in clinical trials

[Paula Wittekind <plwitt@xxxxxxxxxx>]

K.F. Etzold,

Your point came up in the Kentucky hearing, raised by the judge, and it's a
reasonable one.  The patients' attorney's response was that [if a patient
waived his right to sue and then turned around and tried to sue anyway]  he
couldn't see a court ruling in the patient's favor under those circumstances
and said, "that can't be the reason for the withholding."[meaning that was
an unacceptable reason]

Paula Wittekind


----- Original Message -----
From: "K. F. Etzold" <etzold@xxxxxxxxxxxxx>
To: <PARKINSN@xxxxxxxxxxxxxxxxxxxx>
Sent: Thursday, July 21, 2005 11:54 PM
Subject: Re: Editorial: patient choice in clinical trials


> Linda J Herman wrote:
>
> > Many PWP feel strongly that we must never allow another pharmaceutical to
> > treat human subjects in this unethical manner again. We will continue to
> > do whatever we can to convince Amgen to reinstate treatment for the
> > current trial patients and to further develop GDNF for other patients or
> > allow another company to do so.  There is substantial evidence that GDNF
> > works -- and it might be available alot  sooner than other  treatment
> > methods that are still in pre-clinical stages today.
> There is another side to this:  A drug company has to be very careful of
> how it makes experimental
> Drugs  available. Let us say they would agree to make GDNF available to
> PD patients because
> they felt it was the right thing to do. Let us also assume that the
> company would require a waiver
> from the patients. Sounds good so far. But now, after several months
> severe side effects show up
> and some of the patients decide to sue the company, just as they are
> suing now, but in the opposite
> direction.  It is likely that the patients would win the suit despite
> the waivers.
> This would be an unacceptable risk for the company, which is probably
> why they are taking such a hard line. Especially since there appears to
> be reason to be cautious
> based on  the test evidence (which may not be complete). But the courts
> would certainly look at that
> and conclude that the company was reckless, and that the patients
> deserve monetary compensation.
> It would also reflect badly on the public image of the company.
>
> ----------------------------------------------------------------------
> To sign-off Parkinsn send a message to:
> mailto:listserv@xxxxxxxxxxxxxxxxxxxx
> In the body of the message put: signoff parkinsn

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:listserv@xxxxxxxxxxxxxxxxxxxx
In the body of the message put: signoff parkinsn