Hi,
Having been lightly involved in selling computer systems to the
Pharms market, I can tell you:
- they are one of the most heavily regulated industries around
- the US FDA strikes fear into the whole industry, worldwide
- the auditing requirements are pretty onerous. For example in a lab,
you have to be able to prove "that person, on that date, did this to
this exact sample, and there's no possibility of confusion"
If the drug companies say that a particular trial happened, I have no
doubt it did. That's a pretty systematic thing, and the processes are
well known.
When it comes to interpreting the data that comes out of those
trials, and developing prescribing guidelines, that's where human
judgement comes in. I don't know how that happens, and what systems
are in place to ensure its carried out appropriately.
BTW, the reason I say "lightly involved" above, is the stuff I find
interesting (Electronic Lab Notebooks) won't be suitable for the
Pharms market until we figure out how to make the regulators happy.
That is *a lot of work* as in around 10x what it took to write the
original product. That's why everything in the Pharms world is *so*
expensive. Its also why the pace of process innovation in the Pharms
market is so slow (certainly for everything except basic research) -
because the environment you are working is so concerned with the
regulator.
Simon
[snip from Charles T. Meyer]
>Adverse events are taken quite seriously and it is unlikely that a major side
>effect could get through if its incidence is high enough. (but
>possible). (Low incidence side effects can always get through and the FDA
>monitors this closely- hopefully)
>
>You are correct that the bias of drug companies can be expressed and that
>usually is not in the public's best interest. Like Lilly, going for an
>indication to use Prozac for weight control with very questionable data. The
>FDA denied them.
>
>Drug companies can be relatively ethical or pretty slimy and the FDA over or
>under cautious. I wanted to put out the facts as I see them and would
>appreciate any comments or corrections.
--------- My opinions are my own, NIP's opinions are theirs ----------
Simon J. Coles Email: [log in to unmask]
New Information Paradigms Work Phone: +44 1344 753703
http://www.nipltd.com/ Work Fax: +44 1344 772510
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