Earn a little extra cash?

That's a sufficient tank range if it's just going to sit in the garage
;-).

TBH, that is pretty shit though. is that 70 till absolutely empty of 70
till reserve/light etc

Kiran

 

I think you'll find drug companies aren't particularly interested in
objective reporting, they just need some figures that make their new
product look good. Pretty scary stuff.

 

I wouldn't be at all surprised to find out that there has been a major
cock-up with this one. Someting like milligrams instead of micrograms or
other wrong dosage. Its very unlikley that something that shows no
significant toxic effects in animals would cause such immediate and major
problems in humans.

 

I think you mean month.

I know lots of people who worked for AstraZeneca who did many trials.
You get paid handsomely for it and many see it as a perk. Trials tend
to be done on in house peeps cos you know they are likely to be
healthier and more honest than someone walking in off the street.

I have done several trials on AZ compounds, admittedly they only test
on females for a different formulation of a known compound.
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having tested in vitro first. then its a variety of animals in varying
amounts. for most compounds what they find in animals scale up to
findings in humans.

unless its a compound that is likely to cause harm such as cancer
drugs. in these cases they test them on humans with very little hope
who are likely to take anything in the vague hope it might help. one
of the entry criteria for these trials is a life expectancy of > 15
weeks.

These can also be dose escalating trials to find the maximum tolerated
dose. ie the dose which causes too many side effects for the benefit.
they do small numbers of patients (3-6) before they move onto the next
dosing level.

it can also be to prove that the how they are testing can be shown
against placebo. also whether a 50mg tablet gives the same results as
2 25mg. there are many types of Phase I trials.

these are also double blind [1]

yep. these are also double blind trials [1]. it depends on what size
difference the trial is powered to find as to how many peeps are
tested. commonly called Phase II

these are the large scale trials. its after this stage that trials are
submitted for approval by regulatory authorities. commonly called
Phase II. for some compounds its been known to combine phase II & III
as it can reduce the numbers of patients and time.

there's also another stage. post approval marketing studies (phase IV)

I have never seen anything on this scale in the 18 years I've been
working for pharmaceutical companies. It is obviously drug related as
the two who received placebo did not have any complications.

The common term for these reactions are SUSARs. Suspected Unexpected
Serious Adverse Reaction and will need to have a full work up on what
happened and be notified to RAs within 15 days. unless one of them die
in which case shorten that time line to 48 hours.

I do wonder who the drug company is though as Parexel is a Contract
Research Company who test other companies compounds. judging by the
compound type it isn't one of ours though we have a similar compound
so its all ears open at work,.

[1] none of the investigator, any company person apart from the person
who did the randomisation and the person taking the drugs know what
they are taking.
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'Hog said...

Northwick Park Hosp was swarming with ITN, BBC and everyone else's OB
units today.

I have had some amazing shags in the nurses home there.

 

Adrienne M Bonwick said...

My ex-wife did trials when she was a student nurse at the same hospital
these poor sods are in. One of the involved her walking around for two
weeks with a canula stuck in the back of her right hand, when they were
testing the canulas themselves, not the drugs administered through them.
There were no hand jobs for me in that fortnight.

 

Okay, I'm playing devils advocate here. So all the anti-"animal
testers" may have a point here. This appears to be a clear case where
testing on animals has no correlation with testing on humans.

I know this is appears to be a rare one-off case, but isn't it going to
strengthen their argument that testing on animals serves no practical
purpose?

 

Rope said...

My ex-wife was a student nurse there.

 

Eh? "For most compounds, what they find in animals scale up to findings in
humans." Sounds like a perfect correlation to me.

I'll wait to be proved wrong, but I'd have thought testing on animals is
precisely what's made this a rare event, rather than an all-too-common one.

News reports most of the ads for this kind of thing are in mags like TNT
and LAM - if nothing else, somebody's finally found a use for antipodeans
and bokkers on tour. Hurrah!

 

I'm wondering if someone slipped a decimal point. Or three.
Y'know, calculating doses in mg instead of µg, or using body-weight in
grams rather than kilos...

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Or someone didn't read the instructions for the compound, or didn't
follow the trial protocol properly, or dispensed the wrong quantity, or
.....

As we haven't got a clue of what may or may not have happened it's a bit
early to speculate. Let's hope the people recover first.

 

Depending if you just count UK based or go globally. There are hundreds
of thousands of trial cases world-wide per year. If you want to hear
about the various outcomes then I suggest google because the results are
published in the scientific media.

 

Also there is a risk that should you use staff they may encounter
chemicals in their work environment that cause a reaction with the trial
compound under test, or that the trial compound may weaken their
immunity and increase their risk of exposure to something nasty in the
labs.

 

You have no place to make this statement until the report is issues as
to what caused the reaction in the volunteers. It could have been a
simple over-dose by accident.

No, see above.

 

And as for Porton Down...

 

no. absolutely no point at all.

this is a huge anomaly. I wouldn't be surprised if there wasn't a
fuckup i the dosing regimen.

I know of many trials that when tested on animals gave reactions that
caused the drug to be binned. I also know of one drug that was passed
by regulatory authorities for mild/moderate heart failure but when
tested in severe failure it killed people. this effect was seen in
animals but ignored by some of the medics.

what would you prefer, test these on humans instead? remember
thalidomide? that's what tightened the amount and variety of pre
clinical testing.
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there has been a huge push by the pharma industry to make information
easier to find for the general public.

Roche in particular has set up http://www.roche-trials.com/index.html
which lists the results of all of its trials.

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Ohhh, you mean "this case" as in the test that's in the news.

Please disregard.

 

We're also assuming that the volunteers in this case were given the right
stuff, correctly manufactured, under a consistently repeatable manufacturing
process, and in the correct dose.