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This address is for information only. I do not claim that these views
are those of the Statistics Department or of Purdue University.
Herman Rubin, Department of Statistics, Purdue University
hrubin@stat.purdue.edu Phone: (765)494-6054 FAX: (765)494-0558
> In article <1170185993.499164.308...@a75g2000cwd.googlegroups.com>,
>
[quoted text clipped - 16 lines]
> >of 20 patients. It was later tested in fewer than 3,000 patients
> >prior to approval."
> >I mean, why shouldn't the drug makers have to tell the truth?
> >PeterB
>
> Why not? But few doctors tell you as much as the ads.
Since the ads tell you virtually nothing, that's hard to imagine. If
a patient asks his doctor about a particular drug, his doctor will
relate the drug to his patient's risk profile. While over-
prescription is a well-documented problem, an even bigger problem is
use of marketing to suggest that treatment of disease *markers*
effectively treats, prevents, or reduces the risk of, any disease. It
is difficult for doctors to openly question this without being
censured by the AMA, even when they want to.
> Few doctors discuss the risks, and many even do not
> say what the chances of benefits are.
They don't know. A 3-mo. toxicology isn't sufficient to uncover most
serious side effects. Sure, doctors can do a better job of discussing
the risks we do know about, but the real truth is that the most
serious side effects are not known until after drug has been heavily
marketed. With regard to a discussion of the potential "benefits,"
that is only meaningful in the context of gene-level diagnostics,
something not currently available. Since most drugs are designed to
address symptoms in an average patient, it's the *patient* who tells
the *doctor* that a drug is "working." The real question is whether
symptom management is worth the potential trade off in disease
response down the road, maybe 20 or 30 years later (think breast
cancer rates and HRT.) You seem to want to blame doctors, but the
regulatory process is at the heart of the problem here. You may not
know that the drug makers have enormous control over policy-making at
FDA, meaning the industry is largely self regulated. Thankfully,
doctors are starting to turn against this state of affairs.
> However, there was more preliminary testing of Foolidor
> than you state.
What are you talking about? Foolidor is not a real drug, I made up a
name to represent prescription meds in general. The numbers I used
were taken from Eli Lilly's website -- they represent protocols
typical of drug development.
> And the number of patients tested to
> give a reliable risk/benefit analysis cannot be too large
> if the drug is to have a reasonable cost.
You think what a drug costs is more important than human life? You
are Ok with a drug like Vioxx, which may have killed 60,000 Americans
who were never aware of the risks?
> A doctor should be required to tell all this to a patient
> BEFORE issuing the prescription...
You apparently don't read much away from the newsgroups. Doctors
cannot be aware of problems the regulatory process hasn't uncovered in
the first place. Were doctors aware of the elevated risk for breast
cancer resulting from use of HRT sooner than their patients? Did you
see how much breast cancer rates have declined since the use of HRT
has been brought down? Remember, the most serious side effects are
likely to be long term, as anything uncovered earlier can be
considered before drug approval in the first place. The fact that
didn't happen with Vioxx, of course, is a whole other topic.
> , or at least before the
> patient leaves the doctor's office, and can request some
> alternative instead.
Patients should indeed take responsibility for their own health,
however the problem under discussion is not patient intitiative. The
topic here is misleading (even criminal) advertising by the drug
industry. Without meaningful regulation of the drug approval process
and an end to false advertising, the public remains at risk. Since
FDA will not take action for fear of disrupting its funding source
(the drug makers) it is up to the public to demand change by engaging
their representatives in the Senate and Congress.
PeterB