Re: Orphan Drug

On Wed, 15 Mar 2006 15:58:02 -0000, "The Todal" <deadmailbox@xxxxxxxx>
wrote:


"GB" <NOTsomeone@xxxxxxxxxxxxx> wrote in message
news:44182ab4$0$8348$da0feed9@xxxxxxxxxxxxxxxxx
GBP 2000 was reported as being paid to one of the people taking part. I
was surprised it was so high.


I think I'd rather sell one of my kidneys for that sum than take a drug with
unknown side-effects that could conceivably produce multi-organ failure or
maybe cancer in thirty years time, or sterility, or who knows what else.

How could you assess the risk to you as a volunteer? I'm amazed that anyone
is willing to do it. I know nothing about the biochemistry but my guess is
that a drug that results in "enhanced activation of T lymphocytes" might
perhaps result in an auto-immune response of massive proportions. Stop me
if I'm talking bollocks....

You're talking bollocks.

Not because you're wrong but because the immune system is bloody
complex and it's hard to make predictions. Which is why they have to
do clinical trials. This case interests me because I would assume
there are strict ethical guidelines. I don't know what they are but a
quick google landed me on a document here
http://www.mvm.ed.ac.uk/research/govethic.htm entitled
The EU Clinical Trials Directive
which is unlikely to be the best starting point but does indicate it's
a serious subject hedged about by lots of lovely law :)

Guessing I would expect trials typically to be done in vitro and on
animals first. I would expect a pilot study to be done next on
patients who might benefit and who have no other hope. This would be a
controlled study, if the drug turns out to be highly effective, the
trial would be stopped and the treatment offered to the controls. By
the end of the pilot study any severe or frequent bad effects would be
known. Only then would trials be done on healthy people, and then
under very close monitoring. The skimpy report you quoted makes it
sound like some mad scientist conned a thousand healthy volunteers
into drinking his untried evil potion and surprise, surprise, some of
them got ill.

When can we expect demands that the doctors in charge of the trial should be
prosecuted? Were they only obeying orders?

Probably not the doctors but the scientists.
.

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