[Foundation-l] Misplaced Reliance, was Re: Paid editing, was Re: Ban and...
Risker
risker.wp at gmail.com
Mon Nov 1 01:18:55 UTC 2010
On 31 October 2010 21:07, <WJhonson at aol.com> wrote:
> In a message dated 10/31/2010 4:02:44 PM Pacific Daylight Time,
> dgoodmanny at gmail.com writes:
>
>
> > But then it should also be said what studies were NOT funded by the
> > manufacturer, and we do not know that,m because most journals do not
> > specify--and almost none specified in the past. >>
> >
>
> That doesn't excuse us from stating it when it is specified.
> Standards change, and we change with them.
>
>
Actually, I don't see what the manufacturer paying for a study has to do
with anything. At least in North America, and I am fairly certain in other
Western countries, new drugs will not be approved by the regulatory agencies
*unless* they have undergone extensive study, both clinical and
non-clinical, and which *must* be paid for by the manufacturer, and then
subjected to peer review. The only exceptions of which I am aware are for
vaccines and certain "orphan" drugs. Most facilities that conduct clinical
trials of drugs insist on up-front payment of all costs so that precious
health care dollars are not spent on these studies, which often require
additional testing that would not ordinarily be carried out (more blood
tests, medical imaging, other studies, for example). All clinical trials in
all accredited healthcare facilities in North America are cleared through
one or more Research Ethics Boards as well.
So, saying that the manufacturer paid for a study insinuates that they have
done something to affect the outcome of the study, whereas it is actually a
requirement for them to pay for these studies in order to have the drugs
considered for approval. It is the equivalent of automobile manufacturers
having to pay to have their cars tested by various safety organizations.
I don't think it is worth mentioning, unless every time it is mentioned it
is done in a way to tell readers that this is not only normal, it is
required.
Risker/Anne
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