From: tcox@ssrl01.slac.stanford.edu (Tony Cox - (415)926-3105)
Newsgroups: talk.politics.medicine,talk.politics.drugs
Subject: Re: From _Scientific American_
Date: 22 Jan 93 18:00:41 -0800
Organization: SSRL, Stanford Synchrotron Radiation Lab
NNTP-Posting-Host: ssrl01.slac.stanford.edu

In article <1993Jan21.055933.23548@spdcc.com>,
	dyer@spdcc.com (Steve Dyer) writes:
> 
> 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.
> 

   Well, I am not personally aware of the circumstances which lead to
   the creation of the FDA, but it seems to me that Massengill could
   have been charged with a number of more serious crimes - fraud,
   deception, criminal negligence, and multiple manslaughter come to
   mind. Perhaps even conspiracy to murder. Why he was charged with a 
   lesser crime is probably a very interesting story. Is this cause
   and effect as you claim, or a pre-decided policy waiting for an
   excuse to become law?

   My position on the FDA is consistent with my position (from earlier
   posts) on medical licensing. I just do not think that a free
   society should legislate what I do with my own body. If I want to
   fill it with dangerous drugs, that is my own business. Society may
   have an interest in ensuring that I leave enough money to dispose
   of the corpse, but that is where it should end.

   The point to this post is not, however, to expose further my own
   views (unfortunately so uncommon in this `land of the free'), but to
   try to determine the motives of those who would insist on thrusting
   the FDA and drug prohibition laws upon me. After all, this is a
   very unbalanced dichotomy - I have no problem with others
   deciding that they will only take drugs which the government deems
   to be safe, but why the desire for universal inclusion under threat
   of law?

   After considerable thought, I have been able to come up with only
   three possible 'honourable' motives - 1) a love of telling others
   what to do; 2) a belief that `society' knows best what is good for
   an individual; 3) a desire to sacrifice the individual for the good
   of the community. (Dishonourable motives include cornering the drug
   market to drive up prices - can you think of more?)

   I'll leave consideration of the first motive for now, and proceed
   with the motives which those who favour such laws would probably
   prefer to be identified with.

   The balance between individual and society is of course the
   mainstay of the majority of posts to this group. It is not possible
   to prove apriori where the balance point might be  - every
   individual action affects other in some way or another, and a fully
   collectivist society appears to be unstable. But wherever you find
   yourself on the individual<->collectivist axis, surely
   _consistency_ should dictate your approach to what should be
   legislated, and what should fall outside of the legislative domain.

   This brings me to an observation on those who might claim motive 2.
   If you favour government approval of drugs on the basis that
   experts (or bureaucrats) are in a far better position to decide what
   is good for your body than you are, then _how can you possibly
   tolerate continued legalization of tobacco_? 

   We have here, from a supporter of the FDA, an assertion that the
   deaths of 107 people in an isolated instance justifies the
   regulation of drugs. I believe that a figure of 300,000 per _year_
   is the accepted figure for tobacco deaths. Surely consistency
   _demands_ that you should drop everything and work wholeheartedly
   for the criminalization of tobacco.


   What of motive 3? Perhaps many would balk at having it expressed so
   bluntly, but that is exactly what is meant by `controlled drug
   trials', a necessary part of the drug approval process conducted by
   the FDA.

   Suppose I am sticken by disease. I hear of a new drug in the early
   stages of testing. It has already been shown to be efficacious in
   provisional trials. The only way I can get this drug legally in the US
   is by `consenting' to be part of a major controlled trial, relating its
   efficacy to that of other drugs or placebos. I am being used as a
   human guinea pig, so that others may benefit after me (we will
   assume for the sake of argument that the test truly has a
   scientific basis, not a bureaucrat one).

   Now the indications are that the drug does do some good. I would,
   given a chance, willingly take the drug and take my chances.
   My prognosis is very poor without it. I have only a 50% chance of
   getting the drug, and so I am worse off being part of this trial
   than I would be if I could get the drug in other ways. I am having
   part of my life taken from me without due compensation.

   Some questions.

   o - Shouldn't I be getting some compensation (it is, after all, in
   the constitution)? If so, how much, and who should pay?  If not,
   justify societies `takings' from the sick.

   o - The criteria for such trials (number of participants, duration,
   etc.) is naturally determined by statisticians, based upon prior
   estimates of drug mortality, ability to determine patient response,
   potential benefit to society,  etc. right? (..and not, of course,
   by bureaucratic edict..). It is possible to improve the statistical
   accuracy of the trials by eliminating unnecessary variables, such
   as patients dropping out of the program midway. This way, fewer
   patients would be needed for the same statistics, and so there
   would be less `takings'. Why not make dropping out illegal?

   o - Of course, none of this makes sense if people are free to leave
   the country to seek drugs or treatment elsewhere. Perhaps people
   with some diseases should have their passports impounded. AIDS
   patients apparently frequent clinics in Mexico, where unapproved
   (but valued) treatments are available. If statistically valuable
   data could be obtained from patients who prefer to go abroad, would
   you be prepared to support such a passport ban?


   So, all you FDA supporters out there, pick your motive, or invent
   something I havn't thought of. Then prove to me that your position
   is _consistent_. I, of course, dont have to - I havn't tried to
   impose my will upon you. (Hint: it may be simpler and more honest
   to choose motive 1)

Tony Cox, Stanford, CA
Newsgroups: talk.politics.medicine,sci.skeptic