"J" <nswex@nalid;anon> wrote in message
news:47000A99.BA2E44BD@execulink.com...
> FDA clinical trial oversight blasted
> <
> http://www.sciencedaily.com/upi/inde...icaltrials.xml
<... lots of sensationalist reporting elided ...>
I don't know about the FDA, I've never worked there. But I do
know a lot about the National Cancer Institute's database of
clinical trials - and what the reporter claims here is off the
mark.
The part of the NCI that I work in is just the database part that
you see in
http://www.cancer.gov. The clinical trials in that
database, for which the exact count is obviously known, are
checked by contacting the clinical trials lead organization for
each trial once every three months to get updates. All of the
trials there are registered with NCI and must pass some NCI
review before inclusion. The base information for the trial data
comes from the investigators, but the government has pretty
careful regulations about what they have to include and the
supporting documentation they have to produce.
That doesn't mean that all of the NCI trials are approved by the
NCI, some of them emphatically are not. But there are laws about
what a clinical trial investigator must do and, if the
investigator follows the laws, there's no legal way to stop him,
even though the NCI doctors may know full well that he's a
horrible bullshitter who is threatening people's health.
It's a tricky problem to balance proper regulation on the one
hand against over-regulation on the other. There are lots of
companies out there who are perfectly willing to sue the
government and/or call their congressman and cry government
persecution when they are the ones being regulated.
> The inspector general's report calls for the creation of a
> comprehensive database of all clinical trials, a federal
> registry of clinical trial inspectors and increased legal
> oversight.
There is a comprehensive database at
www.cancer.gov for cancer
trials and at
www.clinicaltrials.gov for all trials, including
cancer trials.
I'm not an expert in this, but I think the law requires many of
the trials to be registered. Lots of drug companies try to avoid
registering trials. They don't want to reveal what they're doing
and, if it goes bad (as it usually does) they want to bury the
whole thing and not let anyone know they even did it.
Is our government doing a good enough job? Probably not. But
this stuff is expensive. 200 FDA inspectors, with salaries,
overheads, support staff, etc., must cost tens of millions of
dollars. The place where I work (not all of it devoted to
clinical trials by any means) has 100+ employees and contractors.
Lots of money is being spent on all this, and a great many of the
people I've met who do it are pretty smart and pretty dedicated.
I and many other people I've met put in a fair amount of unpaid
time on top of their regular hours to get the work done.
And, as I indicated above, there can often be an adversarial
relationship between regulators and industry in which the
government can be pretty powerful but not as all powerful as
people imagine it is.
We can't both say that the government isn't regulating industry
enough, and at the same time say that budgets need to be cut and
government regulation has to be stopped. We can't have it both
ways folks.
It's really a tough problem. I don't claim to have the answers.
I do believe in government regulation, but I also believe that it
can get out of hand. There's no magic formula for doing it
right. We have to muddle through as best we can.
Alan
FDA clinical trial oversight blasted 
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