View From The Trenches

U58563 at uicvm.uic.edu U58563 at uicvm.uic.edu
Sun Jul 16 00:53:15 EST 1995


In article <95196.214251U27111 at uicvm.uic.edu>, <U27111 at uicvm.uic.edu> says:
>Well, first I don not claim accrediting labs is a cure all... just
>a step in the right direction.  Second, why not?  It's appears to
>work for clinical labs and forensic laboratories... why should
   If you have an experiment, complete with negative control, demonstrating
the superiority of mandatory state regulation of these laboratories over
voluntary standards established by the person or organization contracting
the services and mediated by an equally well-established independent
inspection service, then I might be convinced.  In the meanwhile, however,
I remain skeptical --- what I see is that every attempt at government
regulation leads not to good science, but to a more widespread acceptance of
fraudulent practices.
   To give a simple example, the production of influenza vaccine is a very
carefully regulated practice.  At every step, there are Standard Operating
Procedures to be followed, forms to be filled out, signatures to be collected.
I know of a certain town, however, where this production is performed; and
what it really comes down to is a group of underpaid temporary employees with
no training whatsoever, who learn before all else to keep spare autoclave
tags handy so that if the equipment doesn't turn up sterile they can -make- it
turn up sterile.  And so on... I've forgotten most of what I heard, but I don't
think it would be unfair to say that there has not been a single batch of flu
vaccine produced by the book in a very long time.
   Which is not to say that the regulations don't have an effect:  all that
paperwork, forged or not, has to be filed anyway; the workers still get all
dressed up for clean-room conditions even if they do spoil the effect a bit by
leaving off the masks... it all costs a considerable amount of money to follow,
even though it accomplishes little.

>I 'think' what you are trying to say here is that regulations will
>have nothing to do with decreasing misconduct?
   Actually, I am suggesting that regulations generally -increase- misconduct,
since now the researcher must claim to be following them all, even though that
is usually foolish and often impossible.  This makes a fraud of an honest
person.

>Or are you saying that the increase in misconduct has nothing to do
>with the lack of regulations?
   IF there were no regulations now (alas, not the case), then surely this lack
could not have caused an INCREASE in misconduct, since there were certainly not
FEWER than no regulations before.

>Define 'business ethics'.... are you talking about the competition
>for funding?  I'm sorry... but I don't get what you are talking
>about here?
   Some examples would be the focus on "productive" (i.e. safe, predictable)
research, the demand for immediately foreseeable applications, the increasing
reliance on partnerships with corporations, the suggestions that everyone
start patenting everything and require non-disclosure agreements before they
ship a plasmid... I was referring mostly to a "climate", rather fuzzily, I'm
afraid.

>But preliminary data for a grant is the last vestige for
>'attempting' to assure monies is being spent efficiently.  If you
   The real defense is the ordinary operation of the grant review process.
The reviewers determine that the personnel in the laboratory are qualified to
do the job, that the equipment is sufficient as stated, and examine the theory
of the project in detail to ensure that it seems possible.  (This is the
voluntary, independent review that I suggested as a "control" at the
beginning of this post).  I don't actually think that a lot of "junk" is
getting through --- the NIH committees rate most grants with the highest
recommendation because they are good science and would yield interesting
results if funded.

>That's why I think we do need lab accreditation and personal
>certification - to help tighten the reign on these types of fraud
>as well.
   Please THINK about this.  Would you really enjoy having some bureaucrat from
some hypothetical office come around with a 10-page checklist, and if you have
too many things misdated in your lab notebook, or don't have a degree in the
one of the list of departments they would designate as appropriate, they ban
you from the laboratory and tell you you can reapply in six months?
   Would you like to come to the lab one day and find a big notice on your
door that because one of your students admitted to cervically dislocating a
mouse when the most recent guidelines say to kill it with carbon dioxide that
your lab is shut down for an indefinite period?
   Regulation invariably causes these sorts of outrages.  If it does not have
enforcement power it is called "toothless", and is meaningless; but if it has
such powers they are inevitably misdirected.  There is not an industry or
recreation, however harmless, that has not suffered and been degraded through
the at best earnest-but-ignorant efforts of legislators to establish standards,
in a few hours around a table, that now must override the reasoned decisions
of the most skilled practicioners of a profession.  Worse, it is seldom the
case that such motives are disinterested --- one can imagine how far a few
hundred thousand dollars from a biotech company holding a patent on a process
would go toward having that process effectively mandated in every laboratory
by a legislator who feels a desire for campaign contributions.

>>   A similar set of arguments can be made concerning patents.  But
>>they are the least of the reasons why a patent system is a poor
>>replacement for basic science.
>So how do we fix this?  What's your suggestions.
   The fundamental suggestion is that people must realize that patents and
copyrights are TAXES.  When they were created in the eighteenth century, this
was still obvious; but the Capitalist Fundamentalists of the modern day have
attempted to obscure this point.  Even industry spokesmen have admitted,
however, that patents on life are a "commercial right" and not "ownership in
the religious sense" when pressed by an alliance of religious officials.
   Once this is recognized, it then becomes thinkable to start looking at the
types of patents being issued, and to ask which ones are actually encouraging
innovation and helping businesses to get started, and which are actually
stifling innovation and sending all the biotech profits to the lawyers.  It
may even become thinkable to ask whether that tax revenue should be going
exclusively to the one who makes the very last step of the invention, or
whether some of it might better be directed to funding basic research.  And
if I were to daydream, I would dream of a scenario in which the importance of
basic research is recognized to the point that the scientific literature is
placed in the public domain, and patent restrictions are completely banished
from the research laboratory.

   As to the Gallo case:  like most of the misconduct cases, the alleged
motivation is profit for a specific result.  In this case the situation is
especially bad because the United States government receives royalties on the
HIV test, which means that if they find Gallo innocent, one inevitably wonders
about their motivations.
   The _real_ dishonesty is in demanding royalty payments that come from the
pocket of each and every person being tested for HIV, on the dubious grounds
of being first to isolate the virus.  Once this intellectually invalid
justification for taxing people for doing something that otherwise public
health officials might well wish to encourage is accepted, any further
dishonesty is implicit in the system, and almost impossible to prevent or
punish.  Note: I am making no statement concerning the guilt or innocence of
Gallo, as I am not an authority on the case.

   You talk about AZT in great detail, but I do not see how this justifies the
existence of the FDA.  In fact, this failure would seem to be an effective
indictment of the FDA to me.  Really, however, this narrow consideration is
irrelevant.  What is relevant is that there were a large number of known
nucleotide analogs, and it was likely that some of them would inhibit HIV
replication; all this was known in 1984 if I recall correctly.  What would have
been the logical course of action in a war, for instance, would have been to
screen them all on HIV cultures in a few months, then try them all out on
patients simultaneously, accepting a few hundred casualties as unavoidable.
In a military campaign, after all, to lose a few hundred people for nothing is
not even much of a disaster --- and AIDS kills more people than many a war.
The way I imagine it, by 1986, it should have been possible to use five or six
of these drugs on AIDS patients in rapid rotation until every last virus was
dead.  Instead, through excessive regulation, each drug has emerged with
elephantine slowness; resistant strains to each have been widely dispersed;
and to this day, it is absolutely illegal to try 5 or 6 such drugs on a patient
and see what happens.
   Unsurprisingly, we are losing the war.
   Meanwhile, more sophisticated strategies have been developed.  I believe
that the paper showing DNA immunization of a mouse against *all* strains of
influenza simultaneously came out in 1993.  Last November the Army took out a
contract to study the treatment as an option for AIDS.  I daresay that if it
were not for regulation, this sort of treatment would not be such a pie-in-the-
sky option as the corporations apparently regard it now!




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