View From The Trenches

U27111 at uicvm.uic.edu U27111 at uicvm.uic.edu
Sun Jul 16 22:03:52 EST 1995



On Sun, 16 Jul 1995 00:53:15 CDT <U58563 at uicvm.uic.edu> wrote:

>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.

???

Who needs an experiment...  walk into a clinical lab and see how
professional people act and perform their work and walk into a
research lab (and since you are at UIC... just about any lab would
do) and see how poorly these people do their jobs.

It's as plain as day and is to night.

And I'm not really sure if I am talking about mandatory state
regulations for research... I'm talking about the government only
accepting grant proposals from accredited labs with certified
personal.  Accreditation and certifications would be provided by
already pre-existing organizations for those fields... which mostly
all have local chapters.

>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.

Again, I'm not really talking about government regulation... the
government would NOT be the ones saying... 'you can only use this
probe for that test.'

I'm talking about people working in research who don't have
expertise in a certain field but yet preforms (and publishes)
experiments anyway out of their field of expertise.

Personal example... an immunology lab which 'wings it' on PCR
studies.

Under my idea... for this immunology lab to receive funding for
experiments which required using PCR - this lab would either have
to collaborate with a molecular lab which is accredited for PCR
work (as obtained by whichever molecular organization which
currently sponsors meeting and symposiums on PCR) OR this
immunology lab would have to hire somebody certified in PCR
techniques (again obtained from the same organization/society).

The only government regulations here is that they cannot receive
monies unless they have the personal and lab environment required
to do the best work possible for that particular field of
study/techniques.

>   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,...
[snip]

Agreed... I've heard (and have somewhat personal knowledge) of
similar frauds of data being supplied to the FDA for initiation of
a phase I clinical study

I know the game... it's similar to the radiation safety issues...
'as long as it all looks good on paper' is all that really matters.

But if a lab was to falsify accreditation or certification
papers... the organizations which gives these out can determine the
truth of the matter.

As for maintaining accreditation... labs would have to go through
yearly inspections for equipment and proper research environments
for that particular field of study. ... with possible examinations
of notebooks.

Like I said... I still have figured out how to do proficiency
testing in a research environment.  And that would indeed require
monthly paperwork (if something can be figured out).

As for certifications... personal will have to pass examines and to
maintain it; must attend an X amount of hours of seminars/meetings
per year in that field of study.

>   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.

Well... it's very hard to hind improper equipment for some specific
fields.  Site inspections can either be done by the individual
accrediting organizations (specific for that field of study)... or
by some national research laboratory accreditation organization?

I don't know the specifics of other fields of study... but my
example would be for cell/tissue culture.  I can walk into a cell
culture room and 'know' within 10 mins. if it's a good one or
not... just by looking at it.

Here again... it's not the government saying "You're a cell culture
lab and thus must have X,Y, and Z."  It would be the Tissue Culture
Association which would come in and say... "You're a cell culture
lab and thus must have a laminar flow hood to be accredited."
...for example.

I'd like to see somebody move a laminar flow hood from one lab to
another for the day of inspection.  That's way too much work -
might as well buy one? :-)

>   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.

We already have that being done by researchers who apply (and win)
grants but lied about the type of equipment they have.

If this lab was to receive accreditation (in order to first even be
qualified for applying for a grant)... they must pass a site
inspection first (again, by the designated organization).

>>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.

But you're talking about an ideal world where people pursue
scientific truths just for the purpose of adding to the pool of
scientific knowledge... and not for greed, ego and politics as such
we have today in the new science of the 90's.

They give us the Patent Reform act but no regulations to maintain
standards... no wonder we are at the point we are.

>>Define 'business ethics'....

>   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.

Oh... you're talking about the 'Patent Frenzy' and the 'Publish or
Perish Syndrome' coupled with the continuous fight over funding
between Basic and Applied Sciences.

o.k.

>   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.

And you honestly don't believe researchers 'Beef up' their data for
these presentations and that in grant funding it's mostly a matter
of who you know rather than what you know?

>>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,...

First, it would not be a bureaucrat... but somebody expertise in my
field of study.

> 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,

Not a degree... but certification for what I was doing.

>they ban you from the laboratory and tell you you can reapply in
>six months?

Not only ban me... but close down the lab and take away funding if
I am doing something outside of my field of certification.

Yes!

A good way to clean out a lot of garbage labs IMHO.

>  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?

Well... if say that lab was doing a study on bone cancer using an
animal model and did cervical dislocation - yes, that lab should be
closed down.  For this would lead to the production of garbage
data.

But if the person running that lab was certified to work on such a
project... they should know better (hopefully?).

>   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.

But ITS NOT THE LEGISLATOR WHO DETERMINES SUCH THINGS!

I am really getting tired of discussing this with you if you
continue to twist my ideas to something which does indeed make
little sense.

When I said that the government should force these changes... I
mean that it will have to be the government which MAKES the
research community standardize itself by making it a part of the
grant system.

BECAUSE there is no way in HELL the research community would do
this all on their own in any attempt to standardize the field!
Because they are too apathetic and could care less about quality of
work.

Thus, if the government wants to cap off research funding and spend
what monies it has more efficiently... then they have to FORCE the
research community to increase it's standards and to weed out
garbage.

We already have organizations and societies which exists which can
be made to give out examines and certify personal.  They can
possibly accredit individual labs as well... but we may want a
national organization for that?  I still haven't worked out all of
the details.  These are just ideas.

THINK about what you are saying... that we can continue to chug
along as we have for the past two decades - slowly running out of
monies with little to nothing to show for it?

>>So how do we fix this?  What's your suggestions.

[snip]

>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.

Well... I think we at least agree on one point... you are also
referring to the repeal of the Patent Reform Act?

>   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.

Well... I think the Dingle Subcommittee report showed us that as
they specifically referred to the cover-up within the HHS/NIH.

>   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.
[snip]

Well... that's only part of it.  I think the REAL dishonesty was
how some of his work was horded until he got his patent and thus
delayed the progress of such a test in the first place... all the
while people were receiving contaminated blood products!

And *I* will make a statement on 'Honest' Bob Gallo... he should be
Tanya Harding's tag team partner and not be receiving a new
building and $16 million in funding.  If Helms wants to cut some of
the AIDS budget... why doesn't he start there?

>   You talk about AZT in great detail, but I do not see how this
>justifies the existence of the FDA.

Again, I did not say this.  I said rushing products through the FDA
is not so good and used AZT as a very good example.

The FDA is underfunded, understaffed and overworked - gee, now lets
cut down on the time period a drug has to go through them.  REAL
smart idea!

>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.

Well... maybe??  But I really don't think so.  ???

But I do know, that instead, we had Bob Gallo fighting his battle
that *his* virus was different from that of the French.  And one of
his explanations as to the 'nearly identical' genetic sequences of
the two viruses... was that HIV in people didn't mutate very much
and there weren't large differences in strains of HIV.

How long did it take us to figure that one out?

And how long will it take us to figure out giveing AZT to pregnant
women and new borns is not such a good idea either?

You never answered my quesiton...where is it written that unborn
children and infants are committed to preform 'acts of bravery' so
that Burroughs-Wellcome [now Galaxo] can attempt to stop the 24%
drop in sells of AZT since the publication of the Concorde Study?

>   Unsurprisingly, we are losing the war.

Unsurprisingly, in more ways than one.

>   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!

How's that?  I am unfamiliar with what you are talking about.  How
about a reference?

-Kathy



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