HDTenEightyP/NetNews huggingface dataset:
From: ebrandt@jarthur.claremont.edu (Eli Brandt)
Subject: Re: From _Scientific American_
Organization: Harvey Mudd College, Claremont, CA 91711
Date: Thu, 21 Jan 1993 09:53:19 GMT

In article <1jkjl4INN3qu@armory.centerline.com> mrh@centerline.com (Mike Huben) writes:
>Imagine if everybody was free to market any drug they wanted any way they
>wanted.  How high would the death toll rise?

No need to imagine it -- study pre-FDA history.  "Elixir of
Sulfanilamide" killed 73; lack of beta-blockers killed a good
fraction of a million.  Sale of lethal products is self-limiting,
while bureaucratic stupidity is self-replicating.

>Mike Huben

	 PGP 2 key by finger or e-mail
   Eli   ebrandt@jarthur.claremont.edu


Xref: sparky talk.politics.drugs:8264 talk.politics.medicine:721 sci.med:24509
From: starr@genie.slhs.udel.edu (Tim Starr)
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
Subject: Re: From _Scientific American_
Date: 27 Jan 93 05:57:44 GMT
Organization: UDel, School of Life & Health Sciences

In article <1k1gkqINN285@armory.centerline.com> mrh@centerline.com (Mike Huben) writes:
}>Sale of lethal products is self-limiting,
}>while bureaucratic stupidity is self-replicating.
}
}Self-limiting at what level?  Tobacco shows no signs of being self-limiting
}because of death of its users at the current level of almost a half million
}a year in the US alone.

This is partly irrelevant.  The pretext for the FDA's powers of prior
restraint is prevention of fraud, not death.  Many may die from tobacco,
but few because they were told tobacco was good for them.

However, the fact remains that tobacco use, even with Federal subsidies for
its growers (thanks to that conservative, Jesse Helms, and his bipartisan
cohorts), and even with scientific apologetics for the industry, is falling.

>Remove limitations on advertising,

Censorship is preferable?

remove
}epidemological studies that show the clear connection, remove programs that
}educate about the hazards, and I suspect that an addictive drug such as
}tobacco could double or triple its toll.

The above is fraudulent - ought there be a Federal agency with the power of
prior restraint over Mike Huben to prevent such fraud?  (It's fraudulent
because it misrepresents the position of those who have criticised the FDA
in this thread.)


Tim Starr - Renaissance Now! - Think Universally, Act Selfishly
starr@genie.slhs.udel.edu

"True greatness consists in the use of a powerful understanding to enlighten
oneself and others." - Francois Marie Arouet Voltaire
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: starr@genie.slhs.udel.edu (Tim Starr)
Subject: Re: From _Scientific American_
Organization: UDel, School of Life & Health Sciences
Date: Sat, 23 Jan 1993 09:15:22 GMT

In article <1jpk85INN2a5@MINERVA.CIS.YALE.EDU> drayer-rebecca@yale.edu (Rebecca Drayer) writes:
}In article <1993Jan22.094510.14223@genie.slhs.udel.edu> starr@genie.slhs.udel.edu (Tim Starr) writes:
}>Yep.  I posted an article about the Fascist Death Authority's censorship on
}>notification of results of aspirin studies on heart disease from the Orange
}>County Register.  The suppliers of aspirin are banned from telling anyone
}>on their labels that their risk of death could be decrease by 40% if they took
}>some each day.  This adds about 20 grand more deaths to their body count.
}
}Was there a reason for this action?  I mean, it doesn't seem conceivable
}that they would have done this completely arbitrarily.  I'm not defending
}the FDA, but on the other hand, I don't want to condemn it until I know
}all the facts.

Of course there was a reason.  Bureaucrats were getting enterprising about
their career advancement.

You may mean: What was the pretext for this?  The rationale for such
exercise of prior restraint is to prevent fraud.  I don't buy it, but that's
what it is.

Tim Starr - Renaissance Now! - Think Universally, Act Selfishly
starr@genie.slhs.udel.edu

"True greatness consists in the use of a powerful understanding to enlighten
oneself and others." - Francois Marie Arouet Voltaire
From: meyer@brahma.edsg.hac.com (Mike Meyer)
Newsgroups: talk.politics.drugs
Subject: Re: Excellent pro-legalization article in _Details_
Date: 21 Jan 93 18:54:24 GMT
Reply-To: meyer@brahma.UUCP (Mike Meyer)
Organization: Hughes Aircraft Co., El Segundo, CA

In article <1993Jan19.053757.1830@udel.edu> peters@buster.cis.udel.edu (Shirley Peters) writes:
>
>There's a great 6 page article on Hemp in the February issue
>of Details.  I can't reprint the whole thing here, but I'll briefly
>summarize.
[...description of article content excised, but it does sound like 
	it covers a lot of good stuff ....]
>If anyone wants to send them a 'thank-you' for a level-headed,
>truthful article, the magazine's address is:
>
>    Details
>    632 Broadway
>    New York, NY
>    10012


Better yet, let's all BUY a copy of the magazine, read the article,
then send letters praising them.  Nothing like an increase in sales for
an issue, and accompanying positive feedback to prod an editor to start 
running more articles like this.

Hell, isn't Details sort of a fashion magazine?  Buying a copy might even
convince a few hemp activists to throw away their tie-dye duds and show
up at rallies looking somewhat photogenic and affluent, and that would benefit 
the cause even more.   
:-)  :-)

You might want to also throw in a plug for TreeFree Eco paper, while you
are at it.  Many magazines will run short items about interesting products in
the appropriate column, and this would certainly fit in that category for
any magazine which is paying any attention to environmental issues.

Mike
Mike Meyer				meyer@tcville.HAC.COM
Image and Signal Processing Lab		
Hughes Aircraft EDSG, El Segundo CA
"Shit happens, but it doesn't *just* happen." -- The Karma Police
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: dyer@spdcc.com (Steve Dyer)
Subject: Re: From _Scientific American_
Organization: S.P. Dyer Computer Consulting, Cambridge MA
Date: Thu, 21 Jan 1993 05:59:33 GMT

In article <1jl57dINN3af@beethoven.cs.unc.edu> bell@cs.unc.edu (Andrew Bell) writes:
>Prove it.  Show some stats from the pre-FDA days, back when all we had
>to save ourselves was our own sub-moronic brains.

In the pre-FDA days (pre-1906 and the Pure Food and Drug Act), the big
problem was patent medicines; nostrums of dubious value and content
(but usually with opium, coca or both as their primary ingredients
along with alcohol).  When there aren't many drugs, there aren't many
ways to hurt yourself.  It's absurd to compare the situation today with
the situation back then.

The watershed event which produced the 1938 Food, Drug and Cosmetics act,
the legislation which produced the first modern FDA, was the release in 1937
of Massengill's Elixir Sulfanilamide, a product which was no elixir at all,
the drug being dissolved in diethylene glycol, a poisonous solvent.  107
people, mainly children, died.  Massengill could only be charged with
releasing a "misbranded" product--their crime was not that it was deadly,
but that they called it an "elixir" (an alcoholic solution) when it wasn't.

Even after this legislation, the trackrecord of the drug industry was not
especially good when it came to safety, especially in the 1950's when
modern chemists started making progress in drug development and drug firms'
marketing departments were only too ready to get them to market and see
wide use.  That decade is littered with drugs released only to be withdrawn
several years later as their toxicity was better understood.  The thalidomide
debacle was the catalytic event which produced the legislation creating
the modern FDA.

Even now you have situations where drugs are withdrawn suddenly (this year,
the antibiotic temafloxacin, and just yesterday, the FDA testing and the
worldwide marketing of Centacor's anti-shock monoclonal antibodies.)
Europe is notably more lax than the US in drug approval, but it is arguable
whether the great majority of these drugs represent any kind of therapeutic
advance.  When most new drugs are crap, and most are, there is a good deal
to be said for caution.

The example in this month's Scientific American of the use of a particular
NSAID in meningitis to reduce morbidity and mortality is a bit of a red
herring.  Even if that particular NSAID isn't available in the US right now,
others are, PLUS, the beneficial effects of steroids in this condition were
widely known and dominated clincal practice, even though they themselves
weren't FDA approved for this use.  If NSAIDs weren't tried instead, this
simply reflects medical practice, not FDA drug lag.  It would be incorrect
to think that the FDA directs how drugs are used by doctors.  It doesn't.

-- 
Steve Dyer
dyer@ursa-major.spdcc.com aka {ima,harvard,rayssd,linus,m2c}!spdcc!dyer
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: cliftonr@netcom.com (Pope Clifton)
Subject: Re: From _Scientific American_
Followup-To: talk.politics.drugs,talk.politics.medicine,sci.med
Organization: Inst. for Epistemological Pathology
X-Newsreader: TIN [version 1.1 PL8]
Date: Sat, 23 Jan 1993 04:26:28 GMT

Tim Starr (starr@genie.slhs.udel.edu) wrote:
: In article <1993Jan19.020022.911160@locus.com> yazz@locus.com (Bob Yazz) writes:
: }And beta-blockers are just one category of drug!
: Yep.  I posted an article about the Fascist Death Authority's censorship on
: notification of results of aspirin studies on heart disease from the Orange
: County Register.  The suppliers of aspirin are banned from telling anyone
: on their labels that their risk of death could be decrease by 40% if they took
: some each day.  This adds about 20 grand more deaths to their body count.

Maybe because taking daily doses of aspirin poses risks in itself, with no
corresponding benefit for those who aren't at high risk for heart attack?
You seem to be arguing that any risks from taking a drug unnecessarily can
be ignored, even when the manufacturer is advertising that drug; yet any
deaths which could even vaguely be attributed either to the prohibition of a
medical drug or restriction on its advertising should be laid at the door of
the FDA.  This seems inconsistent.

If your argument is that average individuals should be trusted/required to
educate themselves from scientific sources about the benefits and risks of
the medical drugs they want to take (and the traffic on alt.drugs gives me
little confidence about their ability) then why would you claim that
advertising is required?  If they can't find out that aspirin is helpful to
high-risk heart attack patients (when it's trumpeted in every newspaper in
the country) doesn't that argue that they won't check sources, and that
there is some need to ensure advertising aimed at them is at least accurate
and truthful?

: }But rather than abolishing the FDA, I'd rather see their proclamations
: }just become advisory.

I would agree with this myself.  Advisory recommendations on use of
medicine, and Truth-In-Advertising type powers to prevent wide-scale
swindling of the public by any unscrupulous manufacturers or distributors.

: Stripping it of the power of prior restraint would be a great improvement,
: but I fail to see why money needs to be stolen to finance an agency to
: evaluate safety and efficacy of medications.

Well, if you think all taxation is theft, then all arguments about efficacy
and social utility of government regulation are irrelevant.  Since you're
not going to convince the majority on that score, please put forward
arguments on some other basis if you want to convince anyone besides the
Libertarian faithful.

  -- Clifton

--
cliftonr@netcom.com     Home: +1 808 521 9073  Work: +1 808 625 3234
Clifton Royston, Pope of the Church of the Subgenius in Paradise
- Dissecting personal psychopathology at the edge of the 20th century -
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: starr@genie.slhs.udel.edu (Tim Starr)
Subject: Re: From _Scientific American_
Organization: UDel, School of Life & Health Sciences
Date: Sat, 23 Jan 1993 09:31:25 GMT

In article <1jpea4INNeh0@duca.hi.com> wright@duca.hi.com (David Wright) writes:
}There's nothing in the material you've included in Huben's post that
}recommends that we "prohibit vice".  Indeed, from the tone of the
}thing, I can't tell whether he's agreeing with you, disagreeing with
}you, or just making a side point.

You don't know him like I do, then.

Tim Starr - Renaissance Now! - Think Universally, Act Selfishly
starr@genie.slhs.udel.edu

"True greatness consists in the use of a powerful understanding to enlighten
oneself and others." - Francois Marie Arouet Voltaire
Xref: sparky talk.politics.drugs:8259 talk.politics.medicine:702 sci.med:24477
From: wright@duca.hi.com (David Wright)
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
Subject: Re: From _Scientific American_
Date: 26 Jan 93 12:51:34 GMT
Organization: Hitachi Computer Products, OSSD division
NNTP-Posting-Host: duca.hi.com

In article <1k2nifINNkc6@beethoven.cs.unc.edu> bell@cs.unc.edu (Andrew Bell) writes:
<<major excisions>>
>
>At least tobacco addicts are only killing themselves.

It's obvious you haven't been paying attention to the reports on
second-hand smoke.

But I'm going to fool you and refuse to express an opinion on what
should be done about

  + tobacco
  + the FDA

  -- David Wright, Hitachi Computer Products (America), Inc.  Waltham, MA
     wright@hicomb.hi.com  ** my opinion, not necessarily Hitachi's **
Xref: sparky talk.politics.drugs:8270 talk.politics.medicine:749 sci.med:24560
From: mrh@centerline.com (Mike Huben)
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
Subject: Re: From _Scientific American_
Date: 27 Jan 93 21:49:55 GMT
Organization: CenterLine Software, Inc.
NNTP-Posting-Host: 140.239.2.36

In article <1993Jan22.041247.918351@locus.com> yazz@locus.com (Bob Yazz) writes:
>mrh@centerline.com (Mike Huben) writes:
>
>| Imagine if everybody was free to market any drug they wanted any way they
>| wanted.  How high would the death toll rise?
>
>Instead of imagining such a ridiculous thing, try imagining something
>realistic: the marketing of pharmaceuticals where the claims made had
>to be true, and product liability would still exist.

That's what we have today with the FDA.  The difference you mean is where the
burden of proof lies.  The FDA places the burden of proof of effectiveness
on the manufacturer.  You probably want to place the burden of disproof of
claims (or proof of harm) on the victim.

>Hey, such a policy is good enough for child safety seats.

Displaying proof of harm or ineffectiveness of child safety seats is much
simpler because trauma is usually immediate and indicative of what caused it.

That's not often the case with drugs, where effects cannot easily be tied to
causes in individual cases, but can through epidemiolgical and laboratory
studies.  For example, there are many different causes of lung cancer:
proving tobacco caused a particular case is difficult because there is a
(much lower) background incidence that could have been the cause, possibilities
of exposure to other causative agents, etc.  Yet we know epidemiologically that
roughly a half million a year die from its effects.

Mike Huben

"Enough of acting the infant who has been told so often how he was found under
a cabbage that in the end he remembers the exact spot in the garden and the
kind of life he led there before joining the family circle."   Samuel Beckett
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: ebrandt@jarthur.claremont.edu (Eli Brandt)
Subject: Re: From _Scientific American_
Organization: Harvey Mudd College, Claremont, CA 91711
Date: Tue, 26 Jan 1993 04:26:24 GMT

In article <1k1gkqINN285@armory.centerline.com> mrh@centerline.com (Mike Huben) writes:
>Self-limiting at what level?  Tobacco shows no signs of being self-limiting
>because of death of its users at the current level of almost a half million
>a year in the US alone.

I don't see how this is relevant to the FDA or to pharmaceuticals.
Are you suggesting that the FDA should regulate tobacco as a drug?
(i.e. prohibit it, given that it's unsafe and medically ineffective)
Or that the FDA should treat addictive drugs, in general, differently
from other?

The long-standing decrease in tobacco use is not *necessarily* due to
"self-limitation", but I suspect that evidence of harm and changing
social factors play more of a role than do increased taxes and the
advertising prohibition.

>Innumerable other drugs are addictive as well.  Addiction itself is harmless
>(except for the cost): it is the toxicity of the drug that is at issue.

Good point.  How many lives do you think could be saved if the FDA
would treat alternative nicotine delivery systems more in line with
cigarettes?  They're not "safe", but even chronic nicotine
maintenance pales next to chronic cigarette smoke inhalation.

>Mike Huben

	 PGP 2 key by finger or e-mail
   Eli   ebrandt@jarthur.claremont.edu


Xref: sparky talk.politics.drugs:8246 talk.politics.medicine:689 sci.med:24447
From: dyer@spdcc.com (Steve Dyer)
Subject: Re: From _Scientific American_
Organization: S.P. Dyer Computer Consulting, Cambridge MA
Date: Fri, 22 Jan 1993 14:32:16 GMT

In article <1993Jan22.100312.14737@genie.slhs.udel.edu> starr@genie.slhs.udel.edu (Tim Starr) writes:
>}Massengill could only be charged with
>}releasing a "misbranded" product--their crime was not that it was deadly,
>}but that they called it an "elixir" (an alcoholic solution) when it wasn't.
>
>If the facts are as you have given them, then Massengill was guilty of
>criminal fraud.  If it couldn't have been prosecuted for this due to some
>defect in the legal system, then it should have been corrected, not abandoned.

I believe it was prosecuted for the crime of misbranding; a slap on the wrist.

>As for the thalidomide cliche: the only reason why it wasn't marketed in the
>USA was because of a delay.  The FDA had no test that would have discovered
>the negative effect of the medication on babies.  In effect, the FDA used
>humans in other countries as experimental animals by accident, then got the
>credit for saving the day when tragedy struck.  It had done nothing to earn
>this "honor."

The reason for the delay was that reports of neuritis in people who took
thalidomide were coming in and Dr. Frances Kelsey, the FDA administrator
in charge of the drug, refused to discount these.  That this avoided a
disaster of the magnitude in other countries was entirely accidental,
but it was a demonstration of an individual's caution which was to an
extent institutionalized later on.  Thalidomide would never get approved
these days as a sedative because of its incidence of neuritis as well as
its other effects on the immune system, even if it didn't cause birth
defects.

>Now, it turns out that thalidomide is approved for treatment
>of patients who aren't pregnant women in other countries, but remains
>prohibited here in the USA.  The FDA is denying this to American consumers.

Thalidomide is not used as a sedative, and its use in other conditions
(an immunosuppressant in diseases like leprosy, iriditis, graft-host
reactions after bone-marrow transplants) is fairly circumscribed.
For leprosy, it can be obtained from the CDC.  Its failure to be marketed
in other conditions reflects the legal climate far more than the drug
relgulatory climate; I do believe there are a couple of companies which
are investigating thalidomide as an "orphan drug" for these other indications.

-- 
Steve Dyer
dyer@ursa-major.spdcc.com aka {ima,harvard,rayssd,linus,m2c}!spdcc!dyer
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
From: hrubin@mentor.cc.purdue.edu (Herman Rubin)
Subject: Treatment of misinformation  Was: Re: From _Scientific American_
Organization: Purdue University Statistics Department
Date: Sat, 23 Jan 1993 13:57:17 GMT

In article <1993Jan22.143216.20358@spdcc.com> dyer@spdcc.com (Steve Dyer) writes:
>In article <1993Jan22.100312.14737@genie.slhs.udel.edu> starr@genie.slhs.udel.edu (Tim Starr) writes:
>>}Massengill could only be charged with
>>}releasing a "misbranded" product--their crime was not that it was deadly,
>>}but that they called it an "elixir" (an alcoholic solution) when it wasn't.

>>If the facts are as you have given them, then Massengill was guilty of
>>criminal fraud.  If it couldn't have been prosecuted for this due to some
>>defect in the legal system, then it should have been corrected, not abandoned.

>I believe it was prosecuted for the crime of misbranding; a slap on the wrist.

So change THIS aspect of the law!  Providing known misinformation causing
harm is direct criminal recklessness, and should be prosecuted as such, with
to the victims being foremost in the penalties.  Putting those responsible
in jail for some number of years helps nobody.

I believe that every person responsible for such misinformation causing death
should at least be culpable for wrongful death.  It is time that the medical
profession and the law realize that when one makes a decision for another, one
personally undertakes responsibility for this decision.  Provide information,
not regulation.
-- 
Herman Rubin, Dept. of Statistics, Purdue Univ., West Lafayette IN47907-1399
Phone: (317)494-6054
hrubin@snap.stat.purdue.edu (Internet, bitnet)  
{purdue,pur-ee}!snap.stat!hrubin(UUCP)
Xref: sparky talk.politics.drugs:8266 talk.politics.medicine:734 sci.med:24530
From: scottj@magic.dml.georgetown.edu (John L. Scott)
Newsgroups: talk.politics.drugs,talk.politics.medicine,sci.med
Subject: FDA and cigarettes (was: From _Scientific American_)
Date: 27 Jan 93 19:07:21 GMT
Followup-To: talk.politics.drugs,talk.politics.medicine,sci.med
Organization: J. Random Misconfigured Site
X-Posted-From: iamac-1.dml.georgetown.edu
NNTP-Posting-Host: sol.ctr.columbia.edu

Andrew Bell writes (in <1k2nifINNkc6@beethoven.cs.unc.edu>):
    At least tobacco addicts are only killing themselves.

David Wright replies (in <1k3tn6INNk1m@duca.hi.com>):
    It's obvious you haven't been paying attention to the reports on 
    second-hand smoke.

Didn't the FDA classify "smokeless" cigarettes as a drug and block their
sale on the grounds that the agency hadn't approved them?  My memory is
unclear on this--can anybody out there confirm or deny it?

Assuming this is the case, it is a transparent attempt to thwart the
removal of the most effective argument against cigarettes: that they harm
others besides the smoker.  In others words, there are anti-smoking
activists who are overjoyed at the prospect of second-hand smoke causing
health problems in non-smokers because that is powerful ammunition for
their cause.  The FDA acted to prevent that ammunition from running out.

Of course, all that assumes that smokeless cigarettes do actually cut down
on the second-hand effects of smoking.  Anybody have any information on
that?

--John L. Scott
Newsgroups: talk.politics.drugs
From: gak@wrs.com (Richard Stueven)
Subject: Re: Anti smoking laws coming up in New Jersey
Reply-To: gak@wrs.com
Organization: Wind River Systems, Inc.
Date: Thu, 21 Jan 1993 18:27:47 GMT

In article 21930@cbnewsj.cb.att.com, mjsst@cbnewsj.cb.att.com (mark.j.schiff) writes:
>If you want smokefree restaurants in New Jersey you must let your
>(or our) legislators know now. 

If you don't want the government telling you when and where you're
allowed to smoke, you must let your legislators know.  (See Mark's
article for contact information.)

Don't let them take away yet another freedom.

gak, a non-smoking proponent of individual rights

---
Richard Stueven       AHA# 22584 |----------| I thought a lot about the last
Internet:            gak@wrs.com |----GO----| game, and I thought I must beat
ATTMAIL: ...!attmail!gakhaus!gak |---SHARX--| them this time.  I thought I must
Cow Palace:            107/H/3-4 |----------| be like a wall and not let them
                                              score.  - Arturs Irbe
Newsgroups: talk.politics.drugs