Re: Orphan Drug

On Fri, 17 Mar 2006 09:39:03 -0000, "The Todal" <deadmailbox@xxxxxxxx>
wrote:


I think the concept has changed back to why people sign the consent
rather than whether they are taking a reasonable risk.

I would like to see a sample consent form (odd, isn't it, that a sample form
isn't available on the Parexel website) but I should think in the usual way
people would sign it without reading it, the way they tick "I Accept" when
installing software.

No it's not odd. They and Tegenero have issued irritatingly bland
press statements but it would be stupid to offer the whole business up
for trial by media let alone trial by blog. "We are working with the
Medicines and Healthcare products Regulatory Agency in the U.K.
(MHRA), to review in detail all of the policies and procedures that
were followed." That would include whether the paperwork was right.

If they ever do wish to clarify anything before the enquiry reports
back, they would be better to confirm or retract their initial
statement that there had been no adverse effects in animal tests.
Publishing a consent form would be interpreted by the lynch mob as an
attempt to say "they signed away their rights and there is nothing you
can do about it".

I would guess that most people in these trials are pretty savvy -
complete dunces would probably not know about the things. They will
want to know about compensation and thus risk. They will probably have
a scientific curiosity as well as a personal interest. And it would be
reasonable for any one of them to assume that amongst the thousands of
other people who have taken part, there would be some who have already
checked the fine print. In fact, the idea that it might be a Shylock's
contract is pretty implausible.

....

In which case, I do not think the parallel with a waiter is valid. The
waiter's uniform in the setting is strong evidence that the black
sludge is edible. Absent any particular reason to think the waiter
wants to poison anyone, the mother's decision to let the child try it
is perfectly rational. The trial volunteer whom you postulate is not
making a rational judgment - though it *could* be rationalized in the
same way as the mother at the hotel. Your theory was that the presence
of the white coats overawes the volunteer into a state of irrational
trust, trust in a man who probably *is* trying to poison her.

My theory is that a volunteer is in no position to give truly informed
consent or to assess the likely risk, and that the presence of white coats
helps to make a volunteer feel secure and looked after. Such assurances as
"don't worry, we've done hundreds of trials like this"(if given) do not
actually tell the volunteer what the chances are of having a near death
experience.

Actually they do. It's less than one in "hundreds".

I don't say that anyone is trying to poison the volunteer,

Just my hyperbole. The doctor *is* intent on trying something that
*might be* poisonous on her.

any more than the
NASA engineers were intending to blow up the Challenger crew.

Bad example! Intent is the only plausible explanation. They launched
even though engineers had been pointing out the problem in clear
detail for several months, saying that a preventable disaster was
inevitable sooner or later if they carried on without doing anything.
.

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