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I think if you do those two things you'd be a long way towards getting the FDA on the right footing. |
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Wed, 11 Jul 2007 19:36:31 -0400 |
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Thunderbird 1.5.0.12 (Windows/20070509) |
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You take ten drugs off the market well, no good deed goes unpunished at
the FDA.
They should be beating on the doors of the FDA demanding change.
Congress is going to have to make them happen. So, for example, if I've
got a drug that can treat bronchitis and now it's going to be used to
treat a urinary tract infection well, that's a new indication.
The blood thinner Coumadin is another example. There is a problem and
the evidence is overwhelming, but we'll just have to wait and see. If
the benefits aren't there we shouldn't be having discussions about
labeling the drug. A very small proportion of drugs represent a new drug
that hasn't been marketed before.
It's the same with the ads that appear in magazines.
This is another way that the FDA has betrayed the American public and
has betrayed the public health.
For those people I'd say they haven't seen the evidence so they don't
really understand how bad the problem is.
They flunked every test and I passed every test. Clearly Vioxx was the
problem.
They're really proud of the fact that I've said it and they're not
afraid to be seen with me.
What did the label accomplish? MANETTE: Have your peers turned against
you?
The FDA has a responsibility to protect the public health. I've been
pretty fortunate in that way. This guy has told the truth.
The blood thinner Coumadin is another example. They can have some
confidence because it turns out that most drugs are remarkably safe.
Industry is saying there are all these lifesaving drugs that the FDA is
slow to approve and people are dying in the streets because of it.
MANETTE: Did your faith as a devout Roman Catholic play any role in the
decisions you made to put your career on the line to report the truth?
Yet, what we're talking about is public health and public health is
nonpartisan. I can't afford to make any mistakes. I've been very
fortunate.
We're getting much better at quantitating the risks. All the ingredients
were there for a disaster. I don't know because then it gets embroiled
in politics.
They're hoping that I'll just become very frustrated and disillusioned
and leave or that I'll slip up in some way so that they can take some
sort of action against me.
I've had a very different experience.
MANETTE: Are you at liberty to discuss some of the problems your
colleagues are finding with other drugs and if so, how widespread is the
problem?
If I walked away from that nobody else would have to do anything. You
set up stringent standards of evidence that might lead to the approval
of safe drugs that actually have benefits to the population.
To preempt that, he offers me this job, which basically would have been
exile to a fancy title with no real ability to have an impact.
Drug safety is about five percent. All the other drugs are no better
than placebo. I've helped to get ten different drugs off the market, and
they're from ten different drug companies.
In the future what we need to do is just take the risks and look hard
and dispassionately at what the real benefits are.
Without attributing bad motivations to the scientists doing those
studies all I can do is point to a strong correlation. You know,
Republicans versus Democrats, the left versus the right, conservatives
versus liberals.
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