Misconduct...reply to Kathy

U27111 at uicvm.uic.edu U27111 at uicvm.uic.edu
Thu Dec 21 18:50:26 EST 1995



On Tue, 19 Dec 1995 15:33:02 -0500 (EST), Alexander Berezin wrote:


>(KATHY):
>> About the only other thing we might try to do is to create laws
>> where there would be legal consequences to pay for such
>> misconduct. I mean, if the ORI is going to determine scientific
>> misconduct on legal grounds [proving intent and all that instead
>> of on scientific or ethical grounds]... then the price to pay
>> should be on legal grounds as well [fines and jail time].

>BEREZIN:
>We don't need extra laws in this case. There are already needed
>laws in existence - unrestricted public acsess of any person to
>ANY information collected on him or her. Anonymous peer review
>(APR) reports on your grant applications and/or papers fall into
>this category, despite legal casuistics (and poweful lobby) manage
>to get them exempted. I personally believe that it is legally
>grey area at best. Only a successful court case against APR can
>make a difference. Howewver, for that new O.J. needs to be
>caught for the scientific misconduct. Highly unlikely.

Well... I don't know then.

All I do know is that this idea of teaching more courses in ethics
[as proposed in July's issue of Science on misconduct]... that this
is not the answer.  Again, it's liking spitting to put out a fire.

And recently I've read where the NIH has decided that they will now
only except one amendment to submitted proposals... thus you can no
longer re-submit, re-submit, re-submit...  And they stated that
that should help keep the quality of those funded higher.  How?

I don't believe this will help in the who you know verses what you
know category... if anything... only those who are best at writing
the proposals [ie. paperwork] will be funded more.  And I have yet
to read a study anywhere which shows those best at government
paperwork are of higher caliber labs(?)  As a matter of fact...
from personal experience working in a VA [government] lab...
those people who were the *most* fanatic for dotting your "i's" and
crossing your "t's" mentality in processing the paperwork... these
were the same people who cared less whether a perishable item was
processed through the loading docks in time... or even whether it
was properly stored otherwise.  For I've seen $30,000-$40,000 in
monoclonal antibodies sit an entire weekend unrefrigerated while
the women processing it cared more for having the proper paperwork
[and that she was going home at 5pm, on a Fri.] then observing it
was perishable and should have been refrigerated!

I really think this new NIH mentality will only be one which helps
to perpetuate the great waste which goes on in our field already
[waste of time, energy and money].  For just think if 80% of those
who can get a proposal submitted on a first try are of this same
type of mentality?


No... I really think prosecution for fraud would do more to help
deter it and clear some of the field out?

Even if some of it is grey area and what have you... at the very
least, if someone is caught and punished with jail time - it would
give others something to think about before attempting it
themselves?

And if you get rid of APR, and put some conflict of interest laws
in place which would be met with possible jail time... that would
also help keep that system cleaned out a bit as well?  For
dismantling APR still would not be enough really.  All that would
do is make what goes on more open... more changeable... but still
not really getting to the core of the problem.


>BEREZIN:
>Fraud is fraud only for as long as there are buyers for it.
>Any swindler knows this ground rule. Create the market first.
>For as long as publish-perish & Co remains in force, cheaters
>will always get smarter and smarter and will (generally)
>oversmart 'ORI' or whatever.

But you see... that's still not getting to the core of the problem
here.  Biotechnology has become *big* business.  The stock market
somewhat depends on it... the connections between academic and
business are becoming stronger and stronger each year where more
and more labs depend upon this for money sources.  And you said it
your self... fraud is fraud as long as there are buyers for it [and
if big money is involved?]

Take Gallo and sp-pg for example [sorry, he is just such a good
example for just about everything which is wrong in our system!]...
anyway, he puts out a paper in Science that this new drug worked
well in an animal model for KS.  ["It really prevents the
development of lesions, " Gallo had said at the time.]

What was not said...

-    The National Cancer Institute struck a commercial development
     deal with Daiichi Pharmaceutical, the Japanese Company that
     owns the US-patent on SP-PG, which quickly begun plans to try
     the drug on American AIDS patients.

-    The NCI declined to disclose the amount of money Gallo's lab
     received from Daiichi, but inside sources put the figure close
     to $75,000.

-    Daiichi's stock gained 6 percent on the Tokyo Stock exchange
     the day Gallo's Science article came out.

And some of the data provided in this article was seriously
questioned by Witte [of which details I will not get into but you
can find it in a June '94 JAMA article].... but who 2 years after
this Gallo paper, still could not duplicate his results in mice.

And last I heard, SP-PG was only tested in 7 patients at
the University of Southern California... where researchers reported
that several of the participates have suffered from unexpected
bleeding and other side effects.  And only 2 of the 7 appeared to
improve since taking the drug...  And then Daiichi pulled it from
further human testing.

Thus, we have gone to far down this road where it's now too later
to retract the Patent Reform Act of 1980 and turn it all around...
thus, we need to create new and better laws to control what goes
how and how well science conducts it's self in this new Science of
the 90's.

[splice]
>BEREZIN:
>I certainly agree with your analogy above for such areas as
>research on AIDS, drug development, etc. But most other areas
>are not that directly sensitive to the issues of public health
>and safety. There are scors of people in any of these areas
>who have all the magnificant life-time careers in science
>producing mountains of garbage nobody ever reads (except, peer
>reviewres, of course).

And that's why Congress can get away with this 'National Needs'
mentality they are trying to use for allocating monies.

No... you make receiving monies dependent upon quality rather then
quantity and then maybe we can get further faster?


Happy Holidays,

-Kathy



More information about the Bioforum mailing list