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From: Steve Harris <>
Subject: Re: Topol and Avorn take FDA to task: asking the wrong questions
Date: 7 Sep 2005 16:49:18 -0700
Message-ID: <>

fresh~horses wrote:
> FDA Taken to Task, Again
> By Amanda Gardner
> HealthDay Reporter1 hour, 46 minutes ago

> Avorn, who is also the author of Powerful Medicines: the Benefits,
> Risks and Costs of Prescription Drugs, focuses much of his argument on
> so-called "lifestyle" drugs, such as those used to treat impotence or
> arthritis pain.
> While a weighing of risks and benefits is particularly important for
> these drugs, Avorn notes the FDA generally does not require such an
> assessment.
> Topol says: "We could separate out lifesaving and lifestyle drugs, and
> I think lifestyle drugs, unless they are having a tremendous impact,
> which is rarely the case, they should be looked at in a different
> light."


The reason we know there is no god, is that neither Topol or Avorn is
likely to be struck with a couple of years of impotence and arthritis,
as just cosmic punishment for their complete lack of empathy.

So what if you're obese, or you can't sleep at night?  Hey, that's not
suffering. It's just a "lifestyle" problem. And we know now, that you
merely want a "lifestyle drug." It's not like you need the drug to save
your life. There you go. A new category of things are born.

So you have urinary incontinence?  You can wear pads or diapers. It's
the Depends Lifestyle--- all the rage now.

Birth control pills?  Well, a new baby will alter your lifestyle, all
right, but that's really all contraception usually is.

And while we're at it, it's a shame the FDA doesn't look at lifestyle
surgeries. All surgery is life threatening, but some surgeries are done
for what can only be called lifestyle reasons. Certainly all the
cosmetic ones. Why can't you just be a little uglier? Maybe the
beautiful people lifestyle wasn't meant for you.

But that's not all. A woman who wants a bladder resuspension because of
incontinence, doesn't have to have it.  There's the good old Depends.
A womam bleeding everyday who wants a hysterectomy or an endometrial
abblation--- hey, that's what tampons are for. Are they not sold as
lifestyle products? Buy a bigger purse.

For that matter, what is breast reconstruction after a mastectomy for
cancer, but a "lifestyle operation"?  It saves no lives.  Prostheses
are available.  A woman missing one or both breasts may have some minor
self image problems or sexual problems, but no worse than an impotent
man has, and we've already determined that THAT's a mere lifestyle
problem. So by logic, reconstructive surgery needs to be looked at more
closely to see if it's "safe." We all must do what's safe.  The
government has decreed this.  The FDA is there to insure that you're
safe, not particularly that you're happy or comfortable.

I will admit that Avorn and Topol have hit on one particular problem
with the FDA, which is that it seems incapable of balancing risks vs.
benefits for drugs, because the agency itself doesn't die, and doesn't
feel pain or social embarrassment, and has no concept of the idea that
there might be kinds of things a person might value in life, which make
that person's life worth living to them. And that different people
might actually have different ideas and values on this subject, and
object to being shoved into the same mold by bureaucrats a long way

So, I have a modest proposal.  Why don't we get some input from
patients themselves, as to the tradeoffs between safety and lifestyle,
in the same way that people decide these things when they buy bicycles,
scuba equipment and sports-cars?  Think of all those interested people,
actually working on their OWN problems! Getting advice from their
personal physicians!  The efficiency of it! Breathtaking. Perhaps, if
it all works out, we could eventually leave the FDA out of the process
almost altogether. What say?

I'm not quite sure what they're doing in this process anyway, are you?
They WERE originally there to make sure foods and drugs were pure,
correctly labeled as to content and dose, and were not frankly
poisonous due to some additive like ethylene glycol.  But somewhere
after that, the FDA got sidetracked into making ethical and aesthetic
judgements for everybody, about what kind of safety tradeoffs are
permitted in changing what is called your "lifestyle."

Is that what we want the federal government to be doing?  Apparently

So, good luck with that bad back and those diapers. Washington doesn't
feel your pain. And it certainly doesn't care if you wet yourself. If
you were privy to more of what goes on behind closed doors in
Washington, DC, you'd wet yourself even more than you do.


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