From: hrubin@pop.stat.purdue.edu (Herman Rubin)
Newsgroups: sci.med
Subject: Access to substances
Date: 21 Aug 92 19:28:18 GMT
Distribution: sci
Organization: Purdue University Statistics Department

In article <1992Aug21.142600.7122@spdcc.com> dyer@spdcc.com (Steve Dyer) writes:
>In article <1992Aug21.104014.3239@news.Hawaii.Edu> lady@uhunix.uhcc.Hawaii.Edu (Lee Lady) writes:
>>And as far as "big deal":  It sounds to me like the new
>>FDA regulations or the proposed legislation now in Congress might make my
>>zinc lozenges illegal.  That would really piss me off.  

>I don't believe that is correct.

>>Besides which, Gordon said that it was crazy to put things in your body
>>that don't have official approval.  I wanted to make the point that as
>>far as I'm concerned his assertion, taken in the generality in which he
>>made it, is totally crazy.  

>I don't recall Gordon saying anything like that.

>>Those are questions of safety.  But when if comes to *effectiveness* let
>>me decide my own level of risk and waste my own money if I want to.  

>I don't see what the problem is wrt nutritional supplements, which by their
>very nature, cannot makes any claims to efficacy.  In the case of prescription
>drugs, the FDA rule requiring proof of efficacy (this was relatively recent--
>early 1960's) ultimately had a far reaching effect on the drugs which were
>sold by pharmaceutical houses, and this effects was all for the good.  You
>couldn't begin to imagine the crap which was sold before that point.  Since
>doctor's have to trust what's claimed by the manufacturer, and act on the
>patient's behalf, a lot of firms were getting rich, and patient's health
>threatened, by the prescribing of drugs which were ultimately ineffective
>or harmful.

I see several serious errors in the above statement.  

1.  Why cannot nutritional supplements make any claim to efficacy?  We are
seeing publications in the refereed medical literature about desirable effects
of "megadoses" of vitamin E, and substantial amounts of beta carotene.

2.  As for requiring proof of efficacy for prescription (and other) drugs,
I can easily describe situations where there will be considerable suffering
and deaths before the drug passes tests of statistical significance, which
is largely what they misuse.  Now suppose someone suggests, on biological
grounds, that taking a drug from early ages will increase life span.  This
is never going to have the proper proof of efficacy, even if it has dramatic
effects.  No matter what we do, errors will be made.  

3.  Many of the bad situations you described (certainly not all) will be 
avoided if the manufacturers and distributors are liable for any withheld
adverse information about the products, but only marginally even for bad
effects if all information is given.  This information must be given not
just to the physician (or maybe not necessarily even to the physician) but
to the patient, who should be the final arbiter.  The information should 
be fully quantitative, so that, in particular, quantitative methods can
be used.  And the patient should have access to the substance, unless there
is a real public health problem such as contagion, even if no physician can
be found to prescribe it.

There are risks and benefits, and the individual must make the decision given
all the available information.  The FDA should insure that the information be
available, instead of using their opinions about good and bad.  Individual
decision making is difficult enough; group decision making is loaded with
quite nasty paradoxes.

-- 
Herman Rubin, Dept. of Statistics, Purdue Univ., West Lafayette IN47907-1399
Phone: (317)494-6054
hrubin@pop.stat.purdue.edu (Internet, bitnet)  
{purdue,pur-ee}!pop.stat!hrubin(UUCP)